Comments

Waitlist Zero | 03/22/2024

Waitlist Zero supports the removal of race from the determination.

UC San Diego Health Center for Transplantation | 03/20/2024

UCSD Center for Transplantation (CASD) appreciates the effort the Minority Affairs Committee put forward in the Proposal to Refit Kidney Donor Profile Index without Race and Hepatitis C Virus as well as the opportunity to provide feedback.

While we support the Committee's efforts, we think it pertinent to point out that this proposal would be better described as a necessary modification reflective of current practice with regards to these two very specific factors. It is unlikely to improve overall acceptance rates.

Given the community's adoption of race-neutral calculations generally and advocacy in advancing HCV+ to HCV- transplant, it is difficult to postulate on the direct impact the policy change, if passed, would have on acceptance behavior. However, the theory of cause and effect would suggest that it would be reasonable to assume some changes, particularly given the modeling suggests that the number of donors moving into a KDPI sequence of 85%.

With regards to the Committee's proposal to refit the KDPI model rather than using a "zero out" method or APOL1 testing, we affirm that the Committee and OPTN have a duty to implement policies based on sound medical judgement al evidence. While the early results of APOL1 testing are interesting, there is not currently enough evidence regarding it's efficacy to include in this iteration of policy.

Mid-America Transplant | 03/19/2024

Mid-America Transplant (MT) appreciates the opportunity to provide feedback to the OPTN regarding Refit of the KDPI without Race and Hepatitis C Virus. As a high-performing organ procurement organization (OPO), MT is committed to its mission of saving lives through excellence in organ and tissue donation, and we are grateful for OPTN’s efforts to improve efficiency in the organ transplant system.
MT strongly supports the proposed revision by the OPTN. The calculation of KDPI should be based on an individual’s unique medical and social history, as well as scientific research factors. Factoring race into the equation is not only unnecessary, but impedes and inaccurately adjusts the KDPI index, which leads to increased wait times and lives lost. Additionally, Hepatitis C Virus can be effectively treated and eliminated post-transplant; therefore, adding it to the KDPI calculation is also an unnecessary impediment to transplantation.
Removing both factors from the KDPI index would positively affect those waiting, as more organs would be utilized for transplant, saving more lives.

American Kidney Fund | 03/19/2024

The American Kidney Fund (AKF) appreciates the opportunity to provide comments on the proposal by the OPTN Minority Affairs Committee, “Refit Kidney Donor Profile Index without Race and Hepatitis C Virus.”

AKF supports the proposal to refit the Kidney Donor Risk Index (KDRI) and subsequently the Kidney Donor Profile Index (KDPI) calculation by removing race and hepatitis C virus (HCV) donor factors to better reflect the likelihood of graft failure for kidneys from African American/Black and HCV positive donors. We agree with the committee’s rationale that race is a poor proxy for human genetic variation because it is a social construct that lacks biological meaning. We also agree that the introduction of interferon-free direct-acting antivirals (DAAs) in 2014 has revolutionized HCV management, and that post-transplant outcomes for HCV positive deceased donors are similar to that of HCV negative donor kidneys.

As the committee notes, currently kidneys from African American/Black and HCV positive deceased donors have an increased KDPI of up to 20% for each factor, making these donor kidneys appear less suitable for transplant. We believe that removing race and HCV donor factors from the KDRI and KDPI calculation is a much-needed step in improving equity in access to transplant for minority candidates.

While African American/Black people make up 13% of the population, they account for more than 30% of kidney failure patients on the national waiting list. In terms of the waiting time for a kidney, 41% of Black patients were still waitlisted for a kidney three years after initially being placed on the waitlist. In comparison, 26% of White patients were still waitlisted for a kidney three years after initial waitlisting. We agree with the committee that since African American/Black patients are more likely to receive kidneys from African American/Black donors, removal of the race coefficient from KDRI could help to decrease the waiting time disparity for African American/Black candidates and non-use of organs from African American/Black deceased donors.

While we support this proposal to remove the race and HCV factors from the KDRI and KDPI calculation, we also want to acknowledge the concern about the potential unintended effects on the pediatric kidney transplant population with changing the use of the HCV factor in KDRI and KDPI. Therefore, we recommend the monitoring of pediatric kidney transplant rates, numbers, and wait times after a change in the KDPI calculation to assess any potential impact.

Thank you for the opportunity to comment on this proposal.

OPTN Transplant Administrators Committee | 03/19/2024

The OPTN Transplant Administrators Committee appreciates the opportunity to comment on the OPTN Minority Affairs Committee’s policy proposal Refit Kidney Donor Profile Index (KDPI) without Race or Hepatitis C Virus (HCV). The Committee supports removing these variables from the KDPI as it is in alignment with enhancing equity within organ allocation. The Committee expresses concern, however, with the reliance on the previous Kidney Donor Risk Index (KDRI) model and variables which were first established in a paper written by Rao et al. (A Comprehensive Risk Quantification Score for Deceased Donor Kidneys: The Kidney Donor Risk Index) in 2009. Members advise that the OPTN and the Scientific Registry of Transplant Recipients (SRTR) reevaluate the entire model more holistically, with a wider range of variables. The Committee recommends a similar approach be taken as it was in 2009 and all variables be reevaluated for their appropriateness to be included or excluded from the KDRI, as the circumstances and environment in which the original analysis was done have changed.

The Committee greatly values the work done on improving equity in kidney allocation and encourages the Minority Affairs Committee to conduct a holistic review of the KDRI to further enhance and promote equity in organ allocation.

Region 10 | 03/19/2024

11 strongly support, 8 support, 2 neutral/abstain, 2 oppose, 0 strongly oppose

Members of the region are supportive of the proposal. The discussion revolved around the Kidney Donor Profile Index (KDPI) and potential modifications to its components. Participants expressed concern over the significant placement of Black donors in higher KDPI categories, pointing out the need for awareness of this disparity. There is overall support for the proposed changes, particularly in relation to Hepatitis C (HCV) and the consideration of Apol-1 data. Concerns were raised about the proposal to remove the Hep C variable without sufficient data and the potential unintended consequences on non-utilization rates. Some participants suggest a broader reevaluation of the entire KDPI, proposing a "KDPI 2.0" to address modern data and potential psychological shifts in its interpretation. Another attendee noted the psychological impact of KDPI, the need for standardizing biopsy processes, and concerns about insurance coverage for HCV treatment post-transplant. The sentiment was generally supportive of revisiting and potentially redefining the KDPI calculation, with emphasis on incorporating modern data and avoiding artificial inflation of KDPI that may lead to organ non-utilization. There was also a call for standardized processing methods and interpretations of biopsies to ensure consistency.

American Nephrology Nurses Association | 03/19/2024

ANNA strongly supports the removal of the race and HCV positive variables from the KDPI to better reflect the likelihood of graft failure for kidneys from African American/Black and HCV positive deceased donors. 

American Society of Nephrology | 03/19/2024

See Attachment

View attachment from American Society of Nephrology

Region 9 | 03/19/2024

5 strongly support, 4 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose

Overall, the region strongly supports the proposal. A member supported the proposal and stated there should be no place in organ donation for bias again certain groups of people and that the community needs to try and increase donation among minority populations. A member expressed strong support and thought that a better solution would be donor testing for APOL1 so donors could be risk adjusted. The member added that it might make the most sense to eliminate KDPI and just use KDRI because KDPI is pejorative. Another attendee stated support for the proposal and wondered if race should be removed entirely from OPTN Donor Data and Matching System because transplant clinicians have been trained to associate higher KDPIs with certain races. An attendee used herself as an example to show what a difference this policy could make and calculated that just by changing her race in the KDPI calculator, her KDPI went from 58% to 40%. Another attendee suggested that ultimately race needs to be removed from the SRTR adjustment models and that perhaps a consensus statement should be submitted to the SRTR. One member stated support for removing race but not removing Hepatitis C. 

OPTN Transplant Coordinators Committee | 03/19/2024

The OPTN Transplant Coordinators Committee appreciates the opportunity to comment on the Refit Kidney Donor Profile Index (KDPI) without Race or Hepatitis C Virus policy proposal.

The Committee voices support for the proposal to exclude race and hepatitis C virus (HCV) from the KDPI calculations. Members echo the sentiment that race is not an accurate biological indicator impacting organ function or longevity. The use of race as a factor in KDPI calculations could potentially dissuade minority donors under the implication that their organs may be discriminated against or perceived as lower quality. Removing potential barriers, such as this metric adjustment, is viewed as a crucial step.

The Committee commends the efforts to address potential sources of bias and discrimination within the organ allocation system and remains committed to promoting equitable access to organ transplantation for all individuals, regardless of race or ethnicity.

Region 6 | 03/19/2024

2 strongly support, 3 support, 8 neutral/abstain, 0 oppose, 0 strongly oppose

Many attendees commented that this proposal does not go far enough and that the entire KDPI calculator needs to be re-examined. Several attendees raised concerns about the impact of removing HCV-related variables on pediatric candidates as HCV positive donors will now be in the 0-34% KDPI sequence. They went on to comment that there is a lack of data to guide management or predict outcomes for use of HCV kidneys in children and most pediatric kidney transplant programs do not have protocols for management of an HCV positive donor kidney. They added that HCV treatment medications are also not FDA approved for use in children under 3 years of age. Some attendees supported removing race from the variable, but not HCV. One attendee supported more APL1 research. One attendee commented that this proposal should not impact how transplant professionals are assessing offers but added that there is a need to look at KDPI and KDRI together when investigating non-use. One attendee offered this reference document: attached

View attachment from Region 6

National Kidney Foundation | 03/19/2024

Attachment

View attachment from National Kidney Foundation

UW Health Organ and Tissue Donation | 03/18/2024

This is long overdue for fairness and equity in our organ allocation system. Race is a social construct and including it as a “risk factor” in the KDPI is racist and biased. HCV is no longer clinically relevant to the same degree as it once was, given the impact of antiviral meds. We support removing race and HCV from KDPI.

NATCO | 03/18/2024

NATCO appreciates the opportunity that the OPTN Minority Affairs Committee has provided to review the proposal to “Refit Kidney Donor Profile Index without Race and Hepatitis C Virus.” NATCO supports removing race and hepatitis C positive variables from the KDPI. Race is not an appropriate, or scientifically based, factor that impacts the longevity of a kidney’s function. Hepatitis C positive organs, in this case kidneys, have proven to be of equal quality to their Hepatitis C negative correlates and with advancements in treating Hepatitis C, more patients have, and will continue to have, access to these organs. Refitting the KDPI model by removing race and hepatitis C positive variables will allow for proper categorization of the quality and utilization of the organs.

American Society of Pediatric Nephrology | 03/18/2024

The American Society of Pediatric Nephrology (the Society) strongly supports the removal of race from the KDPI calculation. This is a long-overdue change, and the Committee should be applauded for moving this project forward quickly.

The Society is concerned about the potential unintended impacts of changing the use of HCV in the KDPI calculation. Children are given high priority in kidney allocation, but that priority is restricted to those donor kidneys with a KDPI of 0-35%; therefore, the method of KDPI calculation is the primary determinant of the donor pool for pediatric candidates. In an analysis that was circulated to the Pediatric Transplantation Committee, approximately 2.3% of the current KDPI 0-35% donor pool is HCV+. Under the proposed changes, 11.4% of the KDPI 0-35% donor pool would be HCV+, with 7.7% of the donors being HCV NAT+. As KDPI is a ranked value, the total size of the KDPI 0-35% donor pool would not be affected. Therefore, the overall effect of this change would be to decrease the number of HCV negative, KDPI 0-35% kidneys offered to pediatric candidates.
While data shows excellent outcomes when transplanting HCV positive kidneys into adult candidates, there is a paucity of data to guide management or predict outcomes for use of these kidneys in children. Consent for receipt of an HCV positive kidney will require detailed conversations with family, discussions that are challenging to have in the absence of any data. The majority of pediatric kidney transplant programs to do not have protocols for management of an HCV positive donor kidney, protocols which will also be challenging to design in the absence of data. Additionally, HCV treatment medications are not FDA approved for use in children under 3 years of age, and there are concerns about insurance approval to access HCV treatment in some patients.

Due to these factors, the Society has a high concern that this policy change will ultimately result in a decrease in the size of the donor pool for pediatric kidney candidates. We recommend some possible steps to address this:
• Refit KDPI to remove race, as originally planned, but avoid changing the HCV-related variables until more study of its impact can be done
• Monitor pediatric kidney transplant rate/number/wait times after any change in KDPI calculation
• Create educational materials for pediatric providers and pediatric candidate families to help navigate this significant change
• Consider increasing the upper KDPI threshold of sequence B kidneys to give pediatric candidates access to the same number of high-quality, HCV negative donors

OPTN Kidney Transplantation Committee | 03/18/2024

The Kidney Committee (the Committee) thanks and applauds the OPTN Minority Affairs Committee for their effort on the Refit KDPI without Race and HCV proposal. The Committee is in support of this proposal, and offered the following comments.

A member remarked that the removal of the race variable will improve the integrity of the greater transplant system, particularly in ensuring race is not a factor in allocation. The member remarked that this integrity is central to appropriately honoring donors’ lifesaving gifts and in conversations with donor families. One member pointed out that there is about a 20 point difference when the donor’s race is selected as African American, holding all else equal. The member remarked that this is a drastic difference, particularly in the context of biracial or multi-racial donors. One member remarked that this proposal is a step towards refining KDPI as a marker for suitability and longevity of an organ, improving the accuracy of this tool. The Committee thanks the Minority Affairs Committee for their efforts to understand the impact of this proposal on future kidney allocation, and in understanding how donors will be redistributed with the removal of the race and HCV variables.

Regional Coalition to Eliminate Race-Based Medicine | 03/18/2024

Attachment

View attachment from Regional Coalition to Eliminate Race-Based Medicine

OPTN Ethics Committee | 03/18/2024

The OPTN Ethics Committee thanks the OPTN Ad-Hoc Minority Affairs Committee for the opportunity to provide feedback on this proposal. The Committee supports this proposal to promote equity. Removing these variables makes sense, as it is now known that the APOL genes confer risk, not race, and that HCV organs are frequently transplanted without incident owing to contemporary treatment. The Committee also notes that KPDI is limited in its predictive ability in general. 

Region 7 | 03/18/2024

8 strongly support, 7 support, 1 neutral/abstain, 0 oppose, 1 strongly oppose 

Members of the region are supportive of the proposal overall, but there were some concerns raised about the removal of Hepatitis C (HCV) as a factor in the KDPI calculation. One attendee acknowledged the need to move past using KDPI as an absolute rule out and to incorporate offer filters for decision making, such as DCD high KDPI, to potentially increase kidney utilization and cut down on cold ischemia time (CIT). Concerns were raised about the impact of race and HCV on allocation, with a call for more data to assess the effects on pediatric kidney allocation and ensure appropriate decision-making. Overall, there is consensus that the proposed changes are overdue and necessary, particularly the removal of race as a factor in allocation decisions. However, there are reservations regarding the HCV component, indicating a need for further evaluation before full support can be given. Since the KDPI calculation is determined by the donor pool and ranks them by a percentage of those donors, there needs to be detailed analysis of how the calculation will change when those two factors are removed from the calculation.

OPTN Pancreas Transplantation Committee | 03/18/2024

The OPTN Pancreas Transplantation Committee commends the efforts of the OPTN Minority Affairs Committee to remove race and hepatitis C virus (HCV) status as variables in the Kidney Donor Risk Index (KDRI) calculation. The Committee offers the following feedback for consideration:

• The Committee raises some concerns that removing these factors from the Kidney Donor Risk Index (KDRI) formula could reduce the predictive accuracy of the model, potentially leading to more use of biopsies to assess kidney quality. The validity and performance of the modified KDPI without race and HCV inputs will need to be closely evaluated.

• The Committee advises that while removing race and HCV from the KDPI is step in the right direction, eliminating the KDRI formula entirely might be preferred over adjusting individual components, to more fully move away from risk adjustments that have perpetuated disparities.

• The Committee recommends that future refinements could consider incorporating other relevant factors such as duration of HCV infection.

The Committee acknowledges that this change represents important progress toward the goal of creating more equitable allocation policies and eliminating the inappropriate consideration of race and other factors.

Region 1 | 03/18/2024

6 strongly support, 7 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose 

A member applauded this proposal and suggested including testing donors for APOL1. An attendee suggested also removing the question about ethnicity from the calculation. They added that the committee should consider the impact on data analysis and scientific research with the plan to retroactively recalculate KDPI. A member asked the committee to consider donors with treated HCV versus donors with active HCV and how insurance protocols might impact the ability to treat recipients of these donors. Another attendee expressed strong support for the removal of HCV status.

Region 5 | 03/15/2024

14 strongly support, 19 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose 

Region 5 supported this proposal and offered the following feedback. An attendee suggested that this should be split apart, where there is KDPI without race, and KDPI and hepatitis C. They noted that pediatric patients only receive priority for KDPI kidneys of 0-34%, and current drugs for hepatitis C are only approved for children three years old and up. They inquired about insurance covering medication for a child less than three years old or a liquid compound for a child that cannot swallow pills. A member commented that the decrease in the KDPI percentage will more correctly represent the true quality of the renal allograft. Another member commented that hepatitis C may need to be left in the KDPI formula as a risk factor. An attendee encouraged donor APOL1 testing when feasible. And if it is not incorporated into the KDPI, it should be available during the organ offer as with all other donor risk factors and test results. 

OPTN Ad Hoc Disease Transmission Advisory Committee | 03/15/2024

The Ad Hoc Disease Transmission Advisory Committee thanks the Minority Affairs Committee for their work on this proposal. The Committee supports the removal of race and Hepatitis C virus variables from the KDPI calculation. 

American Society of Transplantation | 03/15/2024

The American Society of Transplantation (AST) generally supports the proposal, “Refit Kidney Donor Profile Index without Race and Hepatitis C Virus,” and offers the following comments for consideration:

• The AST strongly supports removing race as a variable in calculating the Kidney Donor Profile Index (KDPI), as inclusion of the Black race as a coefficient inaccurately scores the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. The AST also supports removing hepatitis C virus from the KDPI calculations. The removal of these variables supports an evidence-based and more equitable donation and allocation process.

• Evidence provided by the SRTR modeling offers adequate rationale for this approach. Whether these changes will impact acceptance behavior is unclear; refitting the KDPI alone is not expected to cause a significant decline in organ non-use.

• With these changes, the AST also recommends additional study to explore whether these changes impact the predictive power of KDPI. It has been a decade since the implementation of KDPI, and it may be beneficial to rederive the multivariate hazards as described in Rao et al to determine the continued relevance of donor race and other factors on graft outcome using contemporary donor populations.

• The AST appreciates the question of whether the inclusion of APOL1 genes as a potential variable of the Kidney Donor Risk Index (KDRI) should be revisited after data from the APOLLO study become available and the efficacy of APOL1 gene testing is more clearly understood.

OPTN Pediatric Transplantation Committee | 03/15/2024

The OPTN Pediatric Committee understands the intentions of this proposal and supports the removal of race from KDPI calculations.

 The Committee does have serious concerns regarding the removal of HCV and the impact that action will have on potential kidney donors for pediatric candidates. Pediatric candidates only have priority for kidneys with a KDPI of 0-35%. Under this proposal, the total number of KDPI 0-35% kidneys will not change. The percentage of KDPI 0-35% donor kidneys with HCV will increase from 2.3% to 11.4%, with 7.7% of KDPI 0-35% donor kidneys being HCV NAT positive.  The majority of pediatric kidney candidates are not consented for HCV+ kidneys, there is a lack of data on management and outcomes for pediatric candidates who accept HCV positive kidneys, and the medications used to treat HCV are not FDA approved for patients under the age of three years. 

 This proposal could lead to longer waiting times for pediatric candidates. More work must be done to understand outcomes for pediatric transplant recipients of HCV positive organs, establish pediatric protocols for transplant with HCV positive kidneys, educate providers on use of these organs, and educate parents and families on the risks and benefits of accepting HCV positive kidneys. The creation of education materials for these parents and families is critical. The Committee would ask that safeguards be put in place to ensure the potential donor pool for pediatric candidates will not be negatively impacted by this proposal. This should include monitoring of pediatric kidney transplant rates after any change in KDPI calculation.

View attachment from OPTN Pediatric Transplantation Committee

American Society of Transplant Surgeons | 03/15/2024

Attachment.

View attachment from American Society of Transplant Surgeons

Association of Organ Procurement Organizations | 03/14/2024

AOPO supports the proposal submitted by the OPTN Minority Affairs Committee (the Committee) to refit the KDRI (Kidney Donor Risk Index) and related KDPI calculation without consideration of a donor’s race or HCV (Hepatitis C) status to more accurately reflect the likelihood of graft failures for kidneys recovered from deceased African American donors and HCV-positive deceased donors. 

The KDRI, implemented in 2014, uses 10 donor characteristics, including self-reported race, to predict the relative risk of allograft failure. AOPO is in favor of revising this calculation due to its negative impact on acceptance practices by transplant centers because higher KDPI values are associated with lower longevity and donor quality.1 Further, transplant centers are more likely to transplant deceased donor kidneys with low KDPIs to patients with longer estimated posttransplant survival (EPTS).2 The use of the KDRI calculation creates a “labeling effect” in which higher KDPI kidneys have more challenges in placement and a higher risk of nonuse (kidney recovered for transplant but not ultimately transplanted).3 AOPO supports measures to reduce the increasing number of unused deceased donor kidneys each year (totaling over 8,500 in 2023).4 

Additionally, AOPO is supportive of the Committee’s proposal because current research indicates that utilizing the coefficient of Black/African American donor race creates unwarranted disparities. When researchers used the Scientific Registry of Transplant Recipients data to recalculate KDRI coefficients with and without the Black race variable for deceased donor kidney transplants from 1995 to 2005 (n = 69 244), and the recalculated coefficients were applied to deceased kidney donors from 2015 to 2021 (n = 72 926) to calculate KDPI, the race variable had a negligible impact on the model’s predictive ability.5 

When the Black/African American race variable was removed, the proportion of Black donors above KDPI 85%, a category with a higher risk of organ nonuse, declined from 31.09% to 17.75%, closer to the 15.68% above KDPI 85% among non-Black donors. AOPO is hopeful that removing the Black/African American donor indicator from KDRI/KDPI may improve equity without substantial overall impact on the transplantation system; however, AOPO encourages the Committee to comprehensively vet and evaluate revised or new predictive measures to ensure these models are effective and externally validated. 

Similarly, AOPO supports the removal of a deceased donor’s HCV status as a consideration of the KDRI (Kidney Donor Risk Index) and related KDPI calculation due to the chilling effect on organ acceptance by transplant centers, perceptions that the risk of transmission is higher than the true risk for disease transmission, to avoid restricting the usage of organs from certain donors and to reduce the discard of otherwise healthy organs. 

AOPO appreciates the opportunity to comment on the Committee’s proposal, which encourages equity in the organ allocation process and improvements that will assist AOPO in achieving its ambitious goal of 50,000 annual organs transplanted in 2026. 

Jason Rolls | 03/14/2024

I strongly support removal of the race and HCV elements from the KDPI calculation.

I feel like we are gradually whittling away at an already underperforming donor evaluation metric and should be asking the more fundamental question of whether KDPI has outlived its usefulness.

When it was first created, KDRI/KDPI was a welcome change from the binary system of judging donors then in place (SCD/ECD). Some were concerned, however, that people would stop carefully evaluating donors, particularly in the middle of the night, and use the KDPI as a quick, simple, “at-a-glance”, factor in their decision to accept an offer.

This oversimplified crutch has hampered organ acceptance and, consequently, our country’s ability to improve the health of its CKD/ESRD citizens by getting more of them off of dialysis sooner.

KDPI is very limited in its role as a metric to guide organ acceptance decisions because it does not take recipient factors into account. For instance, it may be detrimental to appropriate organ allocation in cases where the potential acceptor is older or smaller than the donor and the transplant professional taking the call does not stop to realize the importance of the score’s limitation.

Also, so many donor organ acceptance decisions are made based on factors not included in KDPI (anatomic; histologic; pump perfusion; many features of medical histories, such as cancer, some types of infections). Therefore, KDPI is not an adequate metric for assessment of our current state of organ allocation and acceptance, and, most importantly, how to improve it.

For the sake of improving organ allocation in our country by having a better understanding of why organs are accepted and refused, and for the sake of more efficient matching of donors with appropriate recipients, KDPI should be put aside in favor of a better system of assessment.

OPTN has access to a substantial amount of donor, recipient, organ allocation, and acceptance data, and statistical analysis resources needed to make sense of these.

Anonymous | 03/14/2024

I ran a simulated donor KDPI with a white donor and a black donor. All other data was identical. The white donor calculated at 44% while the black donor calculated at 63%. Obviously this is a significant difference, and it is very likely that the black donor kidney would be declined by centers due to that number alone. Removing this arbitrary criteria and allowing the donor to be evaluated truly on their clinical picture is a great step in increasing equity in the transplant system.

Gift of Life Michigan | 03/14/2024

We appreciate the work the Minority Affairs Kidney has done to examine current Race and Hepatitis C status in calculation of the Kidney Donor Profile Index (KDPI). We especially appreciate the attention given biological factors over social constructs.

We support the proposal to remove Race and Hepatitis C from the KDPI calculation. We are especially concerned with widespread underutilization of donated kidneys that any artificial factor, such as race, could potentially falsely decrease the KDPI value, thus detrimental to transplantation. It should be removed.

We also agree that available treatment for Hepatitis C is highly effective and should no longer preclude donation of infected organs for some patients.

OPTN Patient Affairs Committee | 03/13/2024

The OPTN Patient Affairs Committee fully supports this proposal and would like to thank the OPTN Minority Affairs Committee for their work. Additionally, the PAC thanks MAC for including PAC members in the workgroup while developing this proposal. PAC supports reconsidering inclusion of the APOL1 gene in KDPI once more data is available. PAC members believe that policies that create a disadvantage for people of color should be assessed and updated asap, as any policy or practice that disadvantages any group should be fast tracked for review as a matter of principle, fairness and equity. Many PAC members believe this policy change may lead to lower non-use rates, increased donation within minority communities, and increased transplant rates, and impact should be measured and monitored carefully going forward. Upon implementation, standardized education for patients regarding HCV organs will be needed, particularly since transplant programs currently are not consistent in the education provided to patients. These educational offerings should include traditional written handouts, as well as educational training videos and should be provided in several languages. These educational offerings should be made available to patients early in the process, perhaps even during dialysis, so they may fully understand any potential risks and benefits of accepting these organs. Following implementation, PAC requests review of the monitoring reports when they become available. Additional feedback from Committee members is enclosed as an attachment.

View attachment from OPTN Patient Affairs Committee

Luke Preczewski | 03/12/2024

While the goal of removing race and HCV status is good, the approach here is the wrong one. Rather than continuing to pluck variable out of an old model on the assumption that it still fits, the entire approach from the Rao paper should be re-created. Using a more recent cohort, all available donor variables should be run in a new stepwise regression to see whether and which should be in the KDPI model. Additionally, the model was run using event variables (degree of HLA match, single/dual kidney, CIT), which then get dropped from KDPI because they are not known. A consistent approach should be taken for that. I defer to the statisticians, but either all variables that aren't known at the time of acceptance should be excluded, or if it is believe the fit is better with adjustment for those factors, recipient variable should also be included to achieve the best fit.
Once the optimal approach is identified, the entire model should be re-run to achieve the best fit possible, and the KDPI updated. The statistical effort required here is not trivial, but easily within the capability of the SRTR or any number of transplant researchers. As we continue to rely on a now very old model, continuing to make tweaks moves further and further from validity. Much as we do for the SRTR risk models, the KDPI should be periodically re-run to include the right variables and achieve the best fit.

I am an employee of an OPTN member, but my comments are submitted on behalf of myself as a transplant professional, not on behalf of my employer nor any other organization.

Anonymous | 03/11/2024

Support

Region 3 | 03/11/2024

9 strongly support, 7 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose

Region 3 supported the proposal. During the discussion there was clarification that this proposal would not change Hepatitis C Virus testing or reporting, it would only remove it from the KDPI calculation.

American Society for Histocompatibility and Immunogenetics (ASHI) | 03/09/2024

The American Society for Histocompatibility (ASHI) and its National Clinical Affairs Committee (NCAC) appreciate the opportunity to provide feedback. ASHI fully supports the removal of donor race and hepatitis C status from the calculation of KDPI.

Region 8 | 03/05/2024

11 strongly support, 5 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose

Region 8 supported this proposal. An attendee supported excluding the race based and HCV variables from the KDPI calculation to better assess the likelihood of graft failures. They inquired whether removing these variables will change the weighting of the remaining variables and accurately reflect risks. They also inquired about the plan to collect post-transplant survival data for kidneys when these variables are removed; and suggested that data collection should begin immediately upon policy approval. A member inquired if APOL1 testing would ever be available whether inside or outside the scope of KDPI. They suggested that Hep C status may still impact the decision to accept an organ but should not influence KDPI. And opined if there are other factors that should be added to improve KDPI predictive ability.

Anonymous | 03/03/2024

I strongly support the removal of race from the KDPI. As has become evident in recent years, it is racism, as opposed to race, that underlies health disparities previously thought to be due to biological differences. Many of these so-called biological differences were also rooted in racism/racist calculations. I support the authors of this paper: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC9208880/ on calling for the removal of race from the KDPI.

Region 2 | 02/29/2024

7 strongly support, 10 support, 3 neutral/abstain, 1 oppose, 0 strongly oppose

Members of the region are supportive of the proposal. Attendees acknowledged the well-reasoned nature of the proposal, but there was a noted concern about the KDPI shifting over time and its potential impact on organ quality. There was a suggestion to remove race from the KDPI calculation but retain Hepatitis C (HCV) as a separate factor due to the specific treatment requirements and lack of reliable options for pediatric patients. While supporting the removal of race, there were calls to carefully examine the impact on pediatric kidney recipients. Concerns are raised about the acceptance of HCV positive donors for pediatric patients, as many antiviral drugs are not approved for those below age 12. An attendee suggested modeling the impact and considering changes in how pediatric donors are classified, possibly excluding children under 18 from the KDPI calculator. Another attendee noted the potential impact on minority individuals especially those with blood type B. By improving the KDPI and moving kidneys into categories that are more likely to be accepted, there is the possibility of enhancing access for minority members with blood type B. Lastly, an attendee encouraged kidney allocation to follow a similar approach to liver allocation by utilizing more HCV positive kidneys to help alleviate the shortage of available organs. The discussion reflected a nuanced consideration of the proposed changes, with a focus on both improving organ allocation and addressing specific concerns related to pediatric recipients and HCV positive donors.

Region 11 | 02/29/2024

7 strongly support, 9 support, 1 neutral/abstain, 1 oppose, 0 strongly oppose 

The region supports the proposal. A member expressed support for the proposal and questioned whether KDPI still meets the community’s needs, as there are misconceptions about what the numbers really mean. An attendee agreed that Black race is an imperfect proxy for a genetic variant causing worse graft outcomes but suggested the OPTN consider requiring APOL1 testing for all deceased donors. Three other attendees agreed that APOL1 testing should be considered. One member remarked that it is okay to acknowledge that racism is why only Black race was factored into these calculations, especially as we make these improvements. One member did not support removing race or Hepatitis C status from the calculation.  

Marc Melcher | 02/27/2024

Neither race nor hepatitis C status should be part of the KDPI.

UAMS | 02/27/2024

Based on evaluation of the proposal to remove race and Hepatitis C Virus from the KDPI, we are in support of this revision. KDPI calculation should be based on individual social/medical history and contraindications supported by scientific research and evidence-based practice. Creating an unnecessary additional barrier that incorrectly represents the quality of the donor organ leads to increased waitlist times and increases the risk of death/deterioration of health of the candidates on the waitlist. This revision would have a positive impact on our patient population and would likely decrease organ non-use and improve patient outcomes both pre- and post-transplant.

Region 4 | 02/26/2024

5 strongly support, 7 support, 0 neutral/abstain, 1 oppose, 0 strongly oppose

During the discussion one attendee supported the proposal and commented that changing that removing race and Hepatitis C from the KDPI calculation will help African American and recipients with Hepatitis C with their transplant outcomes. Another attendee supported the proposal but commented that if KDPI remains “indexed” such that the number of donors in each category will remain similar, it is not clear that this will actually increase utilization. They added that it may increase utilization of donor organs with hepatitis C or of African American race, but there may be a corresponding decrease in other categories if centers continue to use KDPI cut-offs. 

Donald Caillier | 02/25/2024

As a dialysis patient far the past five years, the race of a donor kidney should not be a factor. The important factor is I receive a healthy kidney to replace my failed kidneys before its too late. As a dialysis patient I would never turn down a donated kidney because of race.

Anonymous | 02/21/2024

Anything that unnecessarily creates barriers for people in need should be resolved as soon as possible. People on the waitlist for kidneys already face long wait times while living in pain and discomfort, and it makes no sense for policies to exist that are creating more barriers between these people and the transplant they need. Discrimination and perpetuation of discriminatory practices has no place in the medical world, which should strive to serve all people the way they need to be served: with equity. If there is no scientific basis for race and HCV needing to be a factor in the calculation of the KDPI, it’s only right to remove such factors.

Anonymous | 02/21/2024

Strongly Support

DARLENE COWELL | 02/18/2024

As a candidate for a donated kidney the race of a donor kidney is not an important factor. The important factor is receiving a healthy kidney to replace my failing kidney. As a dialysis patient I would never turn down a donated kidney because of race.

Anonymous | 02/18/2024

As a living, non-directed kidney donor I support the proposed initiative to adjust the current Kidney Donor Risk Index to better reflect the likelihood of organ transplant success. Focusing on individual health instead of race as a determining factor will be a step toward equity in the healthcare system. The current system, which includes the calculation of race and Hepatitis C status, results in the discarding of viable kidneys and disproportionately affects non-white patients on the waitlist.

Melissa Sanchez | 02/09/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Northwest Kidney Centers | 02/01/2024

It is astounding how long the fields of nephrology and transplantation in general have allowed the use of race to determine so many aspects of clinical evaluation and access to care, regarding kidney disease and treatment. It must be acknowledged that this is due to the inheritance of old, staunch beliefs and medical paradigms about differences among races, created in the time of medical experimentation on slaves in the U.S. These old paradigms still infect healthcare in general, but I believe that this proposal is a wonderful first step in retiring these culturally-based (not scientifically-based) paradigms. Removing race and Hep C from donor profiles is long overdue, and I am grateful and fully supportive of this move to correct a long time barrier for so many patients, and the opportunity to significantly improve access for all patients in need of transplantation. Thank you!

Déboralis Ramos | 01/31/2024

Strongly Support

Peter Reese | 01/31/2024

We have carefully reviewed the OPTN proposal for revising the kidney donor risk index (KDRI). Our group comprises doctors, epidemiologists and statisticians. We completely support the MAC’s goal of removing race and hepatitis C serostatus from the KDRI.
However, we have substantial concerns about the transparency of the modeling approach. Given the lack of transparency, it is not possible for outside experts to determine whether the new models meet basic metrics of quality in terms of predictive accuracy. The best quality prediction models have high discrimination, high calibration and ideally, external validation. Reading the report, we cannot ascertain the following:

1) what recipient variables were used in the model; it appears that recipient variables were used both in the original KDPI and this revised model, although the way that recipient variables were modeled is unclear because the KDPI calculation in practice only depends on inputting donor variables;
2) discrimination performance in key demographic subgroups of donors and potentially, in recipient subgroups;
3) calibration performance, which is most transparent when presented visually, and which must be examined in key subgroups. Reporting on Brier scores alone is insufficient.
4) outcomes for the validation of discrimination and validation performance.

We strongly encourage the MAC associated analysts to supplement the report with this detailed information. Without this information, it is not possible for anyone to know if the new KDRI would help, harm or remain neutral to efficiency or equity in kidney allocation. To give a concrete example, bad calibration is quite likely to cause bad decision-making when kidneys are offered to centers. Our group would be glad to collaborate with the MAC in evaluating the work. -Peter Reese, MD PhD and Sarah Ratcliffe, PhD for the Abdominal Organ Quality Prediction Group.

Anonymous | 01/30/2024

Please do whatever can be done to make as many kidneys available as possible! I waited on dialysis for over 5 years. Along with that my transplant hospital that I had to travel5 hours to get to and stay at gave me a Hep C kidney. With just 3 months of medication everything has simply been fine and great! I waited 3 and a half years listed at a hospital that would not give Hep C kidneys and 3 and a half weeks at a hospital that would!!

Northwest Kidney Centers | 01/29/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, Northwest Kidney Centers writes in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in
clinical calculations, and we strongly support OPTN’s proposal to correct this injustice. We encourage OPTN to adopt this proposal and move forward with its prompt implementation.

With gratitude,
Northwest Kidney Centers Staff
https://www.nwkidney.org

National Kidney Foundation | 01/29/2024

I strongly support the National Kidney Foundation in their efforts to eliminate Race or Hep C from the listing of requirements for Transplantation.

Anonymous | 01/27/2024

As a kidney transplant recipient, I know how transplantation can change the trajectory of an individual's life. I strongly support OPTN's proposal to remove race and hepatitis C status as variable when calculating the Kidney Donor Profile Index.

Kidney Champion Foundation | 01/26/2024

I fully support the initiative to better reflect the likelihood of graft failure for kidneys from African American/Black and HCV positive deceased donors.

However, I would like to emphasize that race is a social construct and should not be a factor in determining the suitability of deceased donor kidneys. The decision to include or exclude a kidney for transplantation should be based solely on medical and scientific considerations. The proposed change to remove race and HCV positive variables aligns with the principles of equity and transparency, but it is crucial to underline that racial categories should never be a part of the evaluation process.

In medical contexts, it is essential to focus on individual health factors and medical history rather than relying on race as a determinant. By eliminating race from the KDPI calculation, the organ allocation process becomes fairer and avoids perpetuating inequities associated with a social construct.

I applaud the committee's effort to enhance the KDPI for increased transparency and equity. This change not only aligns with the values of a just healthcare system but also contributes to a more inclusive and unbiased organ transplantation process.

Thank you for considering this perspective as you continue to refine and improve organ allocation policies.

Sincerely,

Crystal King

Jonathan Armenti | 01/26/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index.The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Lisa Burgess | 01/25/2024

Science and evidence should be the basis of any information gathered and/or used to on the Kidney Donor Profile Form. I strongly support removing race and hepatitis C as variable when calculating a patient's Kidney Donor Profile Index. Over 90,000 individuals need a life-saving kidney donation. No family should ever have to face losing a loved one waiting on the list.

Anonymous | 01/25/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index.The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Oliver Baer | 01/25/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race as a variable when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Anonymous | 01/25/2024

By maintaining race as a consideration for a life saving procedure only acts to perpetuate long standing hate and harm to people of color. Race is not a chosen attribute and BIPOC folks shouldn’t have to fight systemic racism while also fighting for their lives.

Anonymous | 01/24/2024

I have CKD and my kidney knows no race and neither do I. I just want a chance to live life to the fullest as a child of God's and humanity.

Quiana Bishop | 01/24/2024

There are many people needing kidney transplants and not being chosen as a candidate because of your race is unacceptable. Everyone is deserving of the opportunity to have a healthy life. Please change this old outdated rule.

Anonymous | 01/24/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Anonymous | 01/24/2024

There are so many people waiting & the younger a person receives a transplant the better. I received one at age 63 after being on dialysis for 3 years. If I had refused a viable kidney from a non Caucasian person, if one was available, I would have been older & maybe had other health issues! We need to erase all areas of racial bias, including transplants. My own daughter just received both a liver & a kidney which had to be from a same matching cadaver. She & I are both eternally grateful just to have a 2nd chance at life!!

Nancy Marlin | 01/24/2024

My understanding that the inclusion of race was not based on data. If so, race should clearly be removed.

Anonymous | 01/24/2024

It's about time restrictions have been lifted.

Michael Kurtz | 01/24/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Karin Ogren | 01/24/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation and as a dialysis social worker, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Anonymous | 01/24/2024

On behalf of the more than 90,000 individuals on the waitlist awaiting a life-saving kidney donation, I write in strong support of OPTN’s proposal to remove race and hepatitis C status as variables when calculating the Kidney Donor Profile Index. The previous policy’s inclusion of Black race as a coefficient inaccurately scored the quality and predicted function of a kidney from a deceased organ donor to be worse than that of a non-Black organ donor. This calculation was not based in science or evidence and had the unintended effect of increasing discards of otherwise viable kidneys. Race has no place in clinical calculations, and I strongly support OPTN’s proposal to correct this injustice. I encourage OPTN to adopt this proposal and move forward with its prompt implementation.

Sarthak Virmani | 01/24/2024

Given the sound rationale shared by the OPTN Minority Affairs Committee members, I strongly support removing the Race and Hep C variables in calculating the KDPI score.