Comments

UC San Diego Health Center for Transplantation | 03/23/2022

CASD strongly supports the proposal to establish a race-neutral eGFR calculation. The data and literature clearly demonstrate that inclusion of the Black race coefficient in eGFR calculations results in an overestimate of Black kidney candidates remaining kidney function and consequently underestimates their medical urgency. Requiring race- neutral eGFR calculations will promote more equitable access to transplantation for those who have been historically been disadvantaged.

Patient Affairs Committee | 03/23/2022

The Patient Affairs Committee (PAC) appreciates the work of the Kidney and Minority Affairs Committees in developing this proposal and the opportunity to provide comment on it. The PAC is in strong support of the proposal to require the use of a race-neutral eGFR formula. This change will help remove a barrier to transplant and improve access for Black kidney patients. The Committee urges transplant programs to proactively stop using eGFR formulas that include a race-based variable. The Committee encourages the OPTN to identify any other race-based transplant related practices or policies that are not supported by scientific or medical research or clinical history and use an expedited review and implementation process to assure the entire transplant experience is race neutral. It is imperative to the patient community that these types of issues be corrected as soon as possible.

Anonymous | 03/23/2022

The OPTN Ethics Committee thanks the OPTN Kidney Transplantation and Minority Affairs Committees for the opportunity to provide comment on their policy proposal. The Ethics Committee is grateful for this policy to correct the long overdue negative impact of race on eGFR. eGFR calculators with the “Black coefficient” underestimate the prevalence and severity of CKD in the Black population, thus resulting in delayed referrals for transplant and delays in qualifying for waiting time. One key unintended consequence of this proposed change is that some living donor candidates may no longer meet minimum eGFR thresholds and will be ineligible to donate. Members emphasized the importance of rectifying the eGFR calculations for individuals who are currently on the waiting list and those who were previously ineligible to be listed. The Ethics Committee suggests creating a detailed plan for implementing these corrections. As a matter of restorative justice (rectification), the OPTN should consider who has been harmed by prior use of eGFR calculators and how those who have been harmed can be made “whole.” This may require an apology to patients who have been harmed, and should consider what corrective action should be taken, especially for patients currently experiencing harm (as those who have been harmed by past use of race-specific eGFR calculations). To ensure equity in access to transplant, we encourage the OPTN to consider the adoption of a single eGFR calculator for waitlist time calculations. The Ethics Committee suggests that this work is continued and race is removed from KDPI.

The Adventist Health Policy Association | 03/23/2022

HPA supports establishing race-neutral eGFR calculations as an option for transplant programs. While the OPTN in general, and the proposed policy, is not prescriptive of any specific eGFR formula transplant programs must use, the current proposed policy change seems consistent with current recommendations in the American Journal of Kidney Diseases (on behalf of the National Kidney Foundation), which is the result of an interim report in the Journal of the American Society of Nephrology (on behalf of the American Society of Nephrology), respectively. If approved and adopted, it will be important for the OPTN to monitor the effects of this policy change to evaluate whether there are any potential unintended consequences. Results from a recent study by Chu and colleagues suggest that “with respect to barriers to kidney transplant, the impact of race in eGFR equations is outweighed by more alarming disparities in CKD progression, a disparity that also impacts Hispanic populations who are not ostensibly disadvantaged by variables used in eGFR calculation. Given the disparities in the rate of CKD progression, it is unlikely that any purely GFR-based approach to the timing of pre-emptive waitlisting, including race-neutral ones such as cystatin C–based eGFR or measured GFR, will effectively remedy disparities in transplantation.” This policy change alone will not likely address all the existing disparities in kidney transplant but may assist the Network with steps that promote equitable access. AHPA recommends that the OPTN strategically partner with subject matter aspects in developing policy solutions that impact clinical practice. The OPTN historically avoids policy changes that could be perceived as prescribing clinical practice. While this stance may seem advantageous, by relying on the generation of scientific evidence and clinical practice from subject matter experts in the field, the reality of competition for organs and donor supply issues may serve the national system’s need to continue to promote efforts that rely on outcomes in policy development. Partnership opportunities will likely remain high given the need to address existing knowledge gaps that have the potential to adversely impact the efficiency and effectiveness of the Network in ensuring equitable access to transplantation. Central to this focus is the question of which kidney disease evaluations and outcomes would best serve the needs of kidney transplant candidates. The Network must continue to strive for reliance on an agreed upon set of measures that can support the pursuit of clinical excellence and competition that delivers better value to patients and families.

Caitlin Peterson | 03/23/2022

eGFR should be race neutral. Race neutrality should also be extend to KDPI. Current formulas increase KDPI for black donors with the only difference being their race.

Anonymous | 03/23/2022

The Committee thanks the OPTN Minority Affairs and Kidney Transplantation Committees for the opportunity to provide feedback on their proposal Establish OPTN Requirements for Race-Neutral eGFR Calculations. The Committee supports this proposal, and has the following comments: 1) The sponsoring committees should ensure that the proposal will not impact candidates in such a way that previously qualifying candidates would no longer qualify based off of changes in a program’s eGFR calculation. 2) The Committee supports the anticipated increase in access for African American candidates. 3) Programs should consider reevaluating the eGFRs of candidates on their waitlist with the goal of updating scores to allow greater wait time for some candidates.

Anonymous | 03/23/2022

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

American Society of Nephrology | 03/23/2022

American Society of Nephrology strongly supports this proposal.

View attachment from American Society of Nephrology

Humana | 03/23/2022

Humana strongly supports the proposal and OPTN’s efforts to promote equity and fairness in transplantation. The removal of race as a variable in the eGFR formula will improve equity and access to kidney transplantation for Black candidates by increasing the accuracy of the formula and will prevent these candidates from receiving delayed treatment.

LaQuayia Goldring | 03/23/2022

Thank you to the wonderful committee members and those in support of race neutral eGFR. As a previous black kidney transplant recipient and current dialysis patient, eliminating race as a means for calculating eGFR will allow for more persons that identify as black or brown persons from any race or ethical background to be fairly listed for a transplant. If you look at the current statistics in our nation, a majority of those in need of transplants are black, brown, or mixed races. Unfortunately, my own family members have found themselves victim to our current race based eGFR calculations, eliminating them from receiving a potentially successful kidney transplant. Therefore, multiple family members have died because of the higher calculation of race eGFR, making it seem like they were less sick. To achieve a fair and accessible chance at better survival rates in transplantation, we must eliminate race immediately! No matter a person's race, when you are waiting for a life saving organ transplant, race eGFR should not be used to punish person's like myself for being black or brown. I strongly support race-neutral eGFR.

American Society of Transplantation | 03/22/2022

The American Society of Transplantation supports this proposal. We agree with such policy, as it increases accuracy and access to transplantation for Black kidney transplant candidates. We wish to offer perspectives for consideration to ensure that this policy ultimately meets the objectives it is meant to address. First, Race and ethnicity differ from genetic ancestry and the concept of ‘race’ is a social construct used to explain differences between groups of people. There is more genetic variation within versus between ‘racial’ groups. While the government uses ‘race’ to track and address disparities, it should not be used as a surrogate of biological function. Likewise, ‘race’ as reported in the electronic medical records has no distinction of multiracial individuals. Furthermore, we do know, as is noted in the proposal, that compared to Whites, Blacks have a higher serum creatinine at the same measured GFR. The CKD-EPI cohort had good representation of Blacks at 31.5%, and recently published data shows that removal of the race coefficient introduces a median bias of -6.1 ml/min/1.73m2 for Black candidates (Diao et al, NEJM 2021). Removing the race coefficient will reduce one kind of disparity in nephrology. The only counterpoint would be if we actually start to underestimate eGFR for all Blacks that will create/ increase CKD burden for several Black individuals and potentially create a preexisting condition with consequences for medical care, drug dosing and barriers in equitable access to health, disability, life and long-term care insurance. Another issue is that the policy is not clear as to whether eGFR or creatinine clearance needs to be indexed for body surface area (BSA). See Policy 3.6.B.i, 8.4A, 8.5G, 9.5H, 9.9B and 13.7G. For example, removing the BSA correction for a person with a BSA of 2.6 will increase his/her eGFR or creatinine clearance by 50% from the indexed value (An eGFR of 19.9 ml/min/1.73 m2 will become 30 ml/min). We agree with the proposal that the transplant programs can use any method for reporting glomerular filtration rate either by direct measure or by estimating it. The formulae must not use a race-based variable. An alternative may be to encourage a cystatin C or other accurate race neutral measure of renal function for transplant referral and for waitlisting. With regards to modifying waiting time for the kidney candidates who are already listed and could have begun accruing waiting time at an earlier data if a race-neutral eGFR calculation was used; this policy could face various challenges. It is possible that many of these patients were not referred to the transplant centers based on the eGFR in the first place, and they may not have been eligible at the time of previous eGFR based on other considerations. Additionally, the programs with a long waiting lists would find it difficult to obtain and update a previous eGFR and convert it into a non-race based estimate. The policy is best served by being implemented prospectively. One of the unintended consequences is the effect on living donors. In the US, living kidney donor programs need creatinine clearance or measured GFR to verify adequate donor kidney function. However, if a program uses eGFR to screen possible candidates, Black donors may be inappropriately ruled out, which would aggravate disparities in living donor transplantation for Blacks. Accordingly, we recommend that post-implementation monitoring also evaluate the impact of these changes on the availability of Black living kidney donors. We do see a need for clear education of hospital administration, transplant and laboratory staff, and IT support to switch from the race based to race neutral eGFR calculator. In summary, there is a need to reduce disparities in access to the kidney transplant waiting list. The current proposal is step in the right direction with removing race from the eGFR equation for wait listing. An alternative may be to require a cystatin C indexed for BSA for transplant eligibility and for wait listing. Of course, these efforts will not result in earlier referral of Blacks to a transplant center, nor will it necessarily prevent disparities in time to complete evaluation once referred to the transplant center.

View attachment from American Society of Transplantation

National Kidney Foundation | 03/22/2022

The National Kidney Foundation supports the proposal, "Establish OPTN Requirements for Race-Neutral eGFR Calculations." Thank you for the opportunity to offer commentary on this initiative.

View attachment from National Kidney Foundation

Anonymous | 03/22/2022

8 strongly support, 13 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose - This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. A member applauded the change, and suggests that reparations should be considered for those who received less time on the waiting list. Additionally, and at the very least, an apology should be given to all patients affected by the previous eGFR calculations.

Anonymous | 03/21/2022

eGFRA should be race neutral. There are enough factors that are taken into account when evaluating patients for kidney transplant. An outdated one has lost its place in the equation.

Anonymous | 03/21/2022

Sentiment: 9 strongly support, 3 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: An attendee commented that race should not be a consideration in organ allocation.

Bryanna Patterson | 03/21/2022

I think this is a great opportunity to expand access to donors who may have been excluded due to the barriers; without increasing risk to donor safety.

NATCO | 03/21/2022

NATCO supports requirements for race-neutral eGFR calculations as proposed. We anticipate that some transplant centers that utilize outside labs will need to confirm that race-based coefficients are not inadvertently being factored into a candidate’s score and that they will need to work collaboratively to examine their eGFR calculations.

Anonymous | 03/21/2022

Sentiment: 7 strongly support, 8 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. Comments: This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. One member stated they strongly support removing race adjustment as it has seemed to impact access to transplant for Black, Indigenous, and people of color.

American Society for Histocompatibility and Immunogenetics | 03/19/2022

The American Society for Histocompatibility (ASHI) and it's National Clinical Affairs Committee (NCAC) appreciate the opportunity to comment on this proposal and are in support of race-neutral eGFR calculations. ASHI supports equitable access to transplantation for all candidates, independent of race.

Anonymous | 03/18/2022

Sentiment: 7 Strongly Support; 5 Support; 1 Neutral/Abstain; 0 Oppose; 0 Strongly Oppose. No additional comments.

Anonymous | 03/17/2022

Sentiment: 8 strongly support, 3 support, 1 neutral/abstain, 0 oppose, 0 strongly oppose. No comments.

American Society of Transplant Surgeons | 03/17/2022

American Society of Transplant Surgeons strongly supports.

View attachment from American Society of Transplant Surgeons

Anonymous | 03/16/2022

The Transplant Coordinators Committee thanks the OPTN Minority Affairs and Kidney Transplantation Committees for their efforts in developing this proposal and the opportunity to provide feedback. The Committee is overall supportive of the proposal, as it improves the equity of recipients and the safety of living donors in the transplantation system. The Committee also suggests a number of possible considerations for the proposal: A prescribed calculation and calculator built into the allocation system; the ability to provide additional wait time for candidates whose eGFR was negatively impacted by race-based eGFR calculations; a guidance document on best practices for programs currently transitioning away from using race-based eGFR. Finally, the Committee comments that laboratories may need to examine their eGFR calculations to ensure that race is not implicitly being factored in a candidate’s score.

American Nephrology Nurses Association (ANNA) | 03/11/2022

ANNA strongly supports.

View attachment from American Nephrology Nurses Association (ANNA)

Johannah Haney | 03/04/2022

Strongly Support

Anonymous | 03/02/2022

Sentiment: 10 strongly support, 7 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose. Members noted any changes should not decrease overall graft survival, and this is an appropriate update to race-neutral eGFR calculations. Commenters also noted transplant programs will require help with updating lab policy and rationale at not only their own centers, but also at all labs.

Milton Mitchell | 02/25/2022

Race must not be a variable here. "When the race variable is used in formulas to assess patients, eGFR calculators only offer two response options: “Black” or “Not Black.” These two options do not allow for mixed race or multi-racial individuals, and do not account for the existing genetic diversity within the Black population." Further, Blacks are basically being denied timely adequate placement on a "Waiting List" because of this. Change this now. Thank you

Anonymous | 02/24/2022

It is clear that current research is in support of using a race neutral calculation for eGFR. I have seen more and more institutions move in this direction and I think this is a great move for us. The national kidney foundation and american society of nephrology's joint task force to assess the inclusion of race in diagnosing kidney disease released it's final report in 9/2021, in which they recommended the adoption of an eGFR without a race variable. The House of Representatives Committee on Ways and Means released an analysis in 10/2021 in regards to the use of race in clinical decision support tools, and came to the same conclusion, recommending immediately implementing new equations to estimate kidney function that do not use race as a factor. The original research for the 1999 study relied heavily on 3 small scale studies for it's findings. In the last 20+ years we have certainly learned more that questions and even contradicts those findings from 99. The current racial component of the eGFR also does not account for those with mixed race ancestry nor the growing racial diversity we see. As we make further advancements in genetics it has become abundantly clear that geographic ancestry, while important, is not the same as race, and the racial categories recognized by society do not exist a genetic level. We are only hindering care to our black patients by failing to acknowledge this and adapt our policy accordingly.

Anonymous | 02/23/2022

8 strongly support, 10 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose - Region 8 supported this proposal. In support of this proposal a member pointed out other areas, other than eGFR calculation, that cause race disparities. For example, patient’s access to insurance, access to referral, social determinants of health care, or decisions made at selection conferences (variations from program to program). A member thought the policy language was vague, explaining that in some places only a GFR is permitted, and in other areas, a creatinine clearance measured or calculated is permitted. Also, the language does not specify if the GFR or creatinine clearance should be adjusted for body surface area. (Where current CKD-EPI equations automatically are expressed per 1.73m2.) The member asked if they now have to be expressed without adjustment. A member stated that it is time to re-assess this value, and if there is no value, then members should discontinue the practice.

Lorri Curto | 02/22/2022

The explanation for the need for this policy states "Recent research suggests that use of the Black race coefficient disadvantages Black patients being treated for Chronic Kidney Disease (CKD)" which is not the same as saying the race coefficient is inaccurate or untrue. I read the original research from 1999 that contributed to the adoption of the race coefficient and it appears that there IS a statistically significant difference in eGFR that is influenced by race. I am not supporting or condemning this requirement but I am wondering what evidence there is that race is not a significant contributor to tolerance for higher levels of creatinine. Would doing away with the coefficient unfairly advantage black transplant candidates over those of other races? I just feel that there needs to be more supportive research cited before demanding such a sweeping change on the part of all participating hospitals.

Johnny Bostick | 02/18/2022

Every person has their own level of eGFR that presents a danger to their life. UNOS needs to set the eGFR threshold and for all and stand by it. Race is too ambiguous a factor considering the high level of mixed races that can go back generations and will continue grow in the future. The world is turning brown, whether we like it or not.

Anonymous | 02/18/2022

10 strongly support, 16 support, 0 neutral/abstain, 0 oppose, 0 strongly oppose - Region 4 supported the proposal and one attendee commented that it was a much needed change to address issues in disparity.

Anonymous | 02/16/2022

There is no need for a race variable. The effectiveness of a kidney should be measured equally between all races. Adding in such a coefficient messes up the accuracy of its function compared to others.

Anonymous | 02/16/2022

13 Strongly Support, 16 Support, 3 Neutral/Abstain, 1 Oppose, 0 Strongly Oppose - Region 5 supported this proposal. Specifically, a member commented that it is imperative eGFR be race-neutral so that all candidates have equal access to transplants.

Anonymous | 02/16/2022

10 Strongly Support, 5 Support, 1 Neutral/Abstain, 0 Oppose, 0 Strongly Oppose - This was not discussed during the meeting, but OPTN representatives were able to submit comments with their sentiment. It was noted that the proposal should be implemented without hast and ensure it is quickly adopted within the waitlist system. Another member suggested the committee use this opportunity to reiterate that timely patient referral to transplant programs is paramount.

Anonymous | 02/15/2022

Race is a social and economic construct not a biological reality so it should not be used to make decisions about who is eligible for a kidney transplant. I say this as a white woman who has received a kidney transplant. Make transplantation and equitable system.

Raenell Transue | 02/15/2022

Evaluations for all kidney transplant patients should be fair and equitable and not use race as a factor, especially if it is a disadvantage to the transplant candidate. All transplant programs throughout the US should be using the same criteria in this regard to ensure fairness and equity.

Robert Steiner | 02/14/2022

I wonder if race neutral eGFR equations will nevertheless make a similar mistake by treating all women, all men, and all older or younger persons as homogeneous creatinine-producing groups. Aside from that, I am not sure that the proposed modifications accurately summarize the current OPTN listing eligibility rule. Current OPTN policy does not mention eGFRS at all, which are estimated size-indexed GFRs. It gives advantages to small people. The proposed modifications do not clearly distinguish between GFRs and eGFRs, which are different things. Measured size-indexed GFRs are not estimates, but eGFRs are. Here is a letter I published in JASN last year. "To the Editors: A recent editorial in JASN addresses an ongoing ethical controversy in kidney transplantation (1). In some borderline cases, only nonblack candidates may have MDRD/CKD-epi eGFRs at or below the threshold of 20 ml/min/1.73m2 that allows accumulation of waiting time on the deceased donor kidney transplant waiting list. Because of the black/nonblack variable, eGFRs may be above this threshold in blacks with the same serum creatinine, age, and sex (2). However, depending on how kidney function is measured, other potentially unfair disparities currently exist. Despite widespread use of eGFRs as threshold metrics, OPTN (Organ Procurement and Transplantation Network) regulations specify only “measured or estimated creatinine clearances or GFRs that are ? 20 ml/min”(3). eGFRs are not mentioned, and they are not the same as GFRs. GFRs and creatinine clearances measure kidney function in ml/min. eGFRs express how well GFR is matched to body size, in ml/min/1.73m2 (4). Although non specialists may consider them almost interchangeable, for most individuals, the numerical difference between their GFR and eGFR is significantly greater that the differences between their MDRD, CKD-epi, and cystatin C eGFRs (5). Because eGFRs are ratios of GFR to size, at the same eGFR (e.g., 21-23 ml/min/1.73m2), creatinine clearances or measured GFRs will often be ? 20 ml/min in smaller candidates but > 20 ml/min in larger ones (4). This will allow waiting time to smaller candidates, who will by definition have the same eGFRs as the larger ones to whom it is denied. Moreover, in the borderline range, isotope determined GFRs will more often be ? 20 ml/min than will measured or Cockcroft-Gault estimated creatinine clearances (4). Under-collection of urine is common and may artifactually reduce measured creatinine clearances to ? 20 ml/min. In other words, irrespective of race, current policy permits certain patients with eGFRs > 20/ml/min/1.73m2 to accumulate waiting time if their physicians simply substitute a more favorable metric. Importantly, at the threshold value of 20 ml/min/1.73 m2, MDRD/CKD-epi and cystatin C eGFRs will significantly underestimate or overestimate actual GFR/BSA ratios in many candidates (5). This will inappropriately allow waiting time to some and inappropriately deny it to others. Even using the most accurate equation (using cystatin C together with MDRD/CKD-epi variables), when eGFRs were 15-29 ml/min/1.73m2, over 15% of the time eGFRs still varied from measured size-indexed GFRs by more than 30% (5). A practical and fair threshold for allowing accumulation of waiting time for decreased donor kidneys is essential, but many unresolved issues remain. We will need input from clinicians, eGFR specialists, and ethicists to best address this issue. "

Jana Killebrew | 02/10/2022

There should be no question about the need to eliminate the use of race in the calculation of eGFR. I am non-black and am livid that a critical gate score for donation (eGFR) currently uses an antiquated formula like this in some facilities. Medical understanding has rendered any potential justification for this coefficient (from past studies) obsolete at best; there is no excuse in 2022 to decrease someone's likelihood for a timely transplant based on race. Eliminate Race in Estimated Glomerular Filtration Rate (eGFR) Equation

Kim Baltierra | 02/04/2022

Support

Anonymous | 01/27/2022

Strongly Support