Comments

Transplant Administrators Committee | 10/01/2021

The Transplant Administrators Committee appreciates the opportunity to provide input on the Minority Affairs and Kidney Transplantation Committees’ request for feedback document Reassess Inclusion of Race in Estimated Glomerular Filtration Rate (eGFR) Equation. The Committee supports this initiative and a member’s program has already taken steps to remove the race coefficient from their program’s eGFR equation. A member suggested developing a report to assist transplant programs that currently use the race coefficient, especially those with larger waiting list populations, to identify candidates with a eGRF near 20 mL/min in order to determine which candidates might benefit from having their eGFR recalculated without the use of the race coefficient.

Colleen O'Donnell Flores | 09/30/2021

Northwell Health has active adult kidney, adult liver, pediatric kidney and adult heart transplant programs. We have an advanced renal team, which altogether spans over 100 years renal transplant experience. Northwell Health wholeheartedly supports the elimination of race as a factor in the calculation of eGFR. We have already made this transition at Northwell. We encourage outside labs to adopt this change, including the major commercial labs, such as Quest and LabCorp, as well as other transplant programs nationwide. Northwell does not stand alone in this. In fact, the National Kidney Foundation – ASN Task Force on Reassessing the Inclusion of Race in Diagnosis Kidney Disease recommends, “the immediate implementation of the CKD-EPI creatinine equation refit without the race variable in all laboratories in the U.S.”. We appreciate the committee’s work to surface the practice. We recognize that the formula on how to calculate eGFR is not presently part of current OPTN policy, however the impact to candidates and referrals who identify as Black is too great. We believe the committee should identify what may be implemented immediately and put forth a policy proposal in the spring, 2022. By allowing race in the calculation of eGFR to continue, we are complicit in the systemic benefit of non-Black candidates for referral and evaluation. As mentioned during our Region 9 meeting, transplant hospitals and commercial labs may adopt this practice in advance of policy and we urge them to do so now. Vinay Nair, MD, Medical Director, Kidney Transplantation, Northwell Health Colleen O'Donnell Flores, MHA, Organ Transplant Regulatory Affairs

Anonymous | 09/30/2021

The Ethics Committee appreciates the work of the Minority Affairs and Kidney Transplantation Committees in developing this document and for the opportunity to comment on it. The Ethics Committee is supportive of using a race neutral formula for GFR. Adjusting the policy to prohibit race-based calculations would increase the transparency of the system, develop a more equitable transplant system, and increase patient autonomy. A member noted the discrepancy in calculations used for pediatric and adult candidates wherein race is only factored in for adult candidates. In an effort to develop a more consistent and equal policy, regardless of race or age, a race-neutral calculation should be required. Overall, the Ethics Committee is appreciative of the opportunity to provide feedback and encourages all centers to make the change to race-neutral calculations while this policy is developed.

Anonymous | 09/30/2021

The mother of a kidney patient supports this eGFR public comment. Her son is young (40ish) and has been on the list for 5 years with no other medical barriers to transplant. Dialysis is taking a toll on her son who does not smoke nor has ever used drugs and only weighs 119 pounds. As such, she feels not enough weight is being given to prioritizing matching Black donors to Blacks first before considering matching Black donors to other races. She states that murder rate is high among young Blacks in Georgia and their organs are being recovered and transplanted into Whites instead of Blacks. She also believes that candidates for transplant who have led destructive lifestyles which led to their kidney failure should not receive the same priority as candidates whose kidney failure is due to natural causes. She believes that Black donors are being given to too many other races and patients that are too old and White.

Anonymous | 09/30/2021

Comments: Several attendees supported moving to a race-neutral equation. One attendee commented that the committee will need to determine how to transition registered candidates who have an eGFR based on a calculation with the race coefficient. Two attendees supported eliminating the GFR qualification altogether since most patients go on dialysis. One attendee went on to comment that patients who get transplanted pre-dialysis do better but that is at the consequence of other patients remaining on dialysis. This attendee commented further that children are the only patients that should be listed and transplanted preemptively. Another attendee supported using a race-neutral calculation and went on to recommend making the same changes for the eGFR in the SLK listing policy. Two attendees commented that since there are currently no policies prescribing what formula you must use, programs can move to race-neutral now. Another attendee cautioned that while we have a race neutral equation, it still remains imprecise and that is the bigger question that we are responsible to answer. They went on to say that removing the race coefficient will reduce one kind of disparity in nephrology, but 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. Further, they added that formulas are a wonderful guide but require clinical judgement.

NATCO | 09/30/2021

NATCO appreciates the work of the OPTN Minority Affairs and Kidney Transplantation Committees in the effort to reassess inclusion of race in the eGFR calculation, as we believe that using a race neutral eGFR may result in earlier referral for ESRD and for accruing waiting time for those identified or identifying as black. We offer the following comments with respect to your request for feedback: Risks or unintended consequences of the proposal as written, may result in a bias that it could be construed as disadvantaging whites or other non-Black patients. It is problematic that most labs are continuing to publish eGFR results with the race distinction. With respect to how the transplant community will educate and/or inform patients about the changes, it will be very important that patients understand the rationale for race neutral eGFR, particularly if this is implemented before labs stop publishing results with race distinction. With respect to post-implementation monitoring, will members be expected to use the non-Black eGFR for all patients? Race is also used to stratify other risks including rejection and subsequently, immunosuppression dosing. How race is identified should be discussed and standardized. We believe that this is a very important initiative and should be moved forward.

Society for Transplant Social Workers | 09/30/2021

The Society for Transplant Social Workers is a strong proponent of using a race neutral eGFR calculation and it's related benefit of increasing access to timely transplant services. The concept of race is a social construct and an unreliable proxy for potential genetic differences, therefore should not be used in the clinical setting. The use of the race adjusted eGFR has most certainly systematically delayed access to kidney transplantation as the calculation inaccurately reflects loss of kidney function. We appreciate the work of the Committee to move this important issue of equity to the fore and support the move to race neutral GFRs.

Anonymous | 09/30/2021

The Patient Affairs Committee (PAC) appreciates the work of the Kidney and Minority Affairs Committees in developing this request for feedback and the opportunity to provide comment on it. Overall, the committee is in strong support of requiring the use of a race-neutral eGFR equation. The PAC would like to see this change as soon as possible, and they would like to help however they can to support this work. Many of the members expressed that they were never aware of the use of a race coefficient. A member also pointed out that having this as a binary option, either “Black” or “Not Black” does not make sense. This member also recommended that the committees make sure to focus on the scientific reasons for making these changes. A few members stated that they would be bringing this up to their own centers to ensure that they use a race-neutral formula. A member added that this is one example of a way that transplant centers handle things differently, and in this case, it can result in disadvantaging some patients. One member expressed concern about the level of knowledge that patients are expected to have, especially regarding protocols that are handled differently depending on the center. The member added that a patient’s health outcome can depend on whether they know the right questions to ask or are confident in advocating for themselves.

Anne Burnley | 09/29/2021

Diversity, Inclusion and Equity is at the heart of why reassessment of the Inclusion of race in the calculation of eGFR is of paramount importance.

Transplant Coordinators Committee | 09/29/2021

The Transplant Coordinators Committee (TCC) appreciates the work of the Minority Affairs and Kidney Transplantation Committees in developing this document and for the opportunity to comment on it. Members was overwhelmingly supportive of a race neutral formula. Members noted that race is not quantifiable, should not disadvantage recipients, or be determined by another individual aside from the patient. Since race is not used in pediatric formulas, there is a major discrepancy in eGFR scores for a candidate who is 17 and turns 18 years old. In an effort to be consistent, a member suggested removing the race coefficient from the Kidney Donor Profile Index (KDPI). Ultimately, members do not want race to impact a patient’s ability to access transplant and want all patients to have the same advantages. Currently, centers have the choice to use a race neutral formula and are not required to use a race-based formula, a member noted that there needs to be a large education effort on this within the community. A member suggested gathering data from centers who have transitioned to a race neutral formula to gain a better understanding of any potential impacts and guide the development of this policy. In the interim, coordinators plan to urge their centers and peers to use a race neutral formula and further discuss this topic. Overall, the TCC is supportive of requiring a race neutral eGFR formula and is appreciative of the opportunity to provide the transplant coordinator perspective.

PALLAVI Gowda | 09/29/2021

The way chronic kidney disease has been categorized for African Americans is long over due. The implications of this update are wide and the field of organ procurement and transplant is a perfect example as more eligible candidates qualify now. So proud of our scientists who made this happen.

American Society of Transplant Surgeons | 09/29/2021

The American Society of Transplant Surgeons (ASTS) appreciates the request for feedback from the OPTN Committees on Minority Affairs and Kidney Transplantation regarding the Estimated Glomerular Filtration (eGFR) rate tool and its highly negative impact on the community. The ASTS strongly supports the OPTN document in the recommendation to eliminate the use of race in the calculation of eGFR. We know that the use of race in such a way is a vestige of misguided and archaic beliefs in a supposed biological difference between Black people and people of other races. However, as our understanding of human biology has evolved over the years, so should our use of these common clinical metrics. It is important to begin by noting some overarching clinical truisms about race and transplantation. First, race is a social construct that is often used in clinical decision making and research as a surrogate for specific (and increasingly identifiable) biological processes. As noted by several NIH leaders in 2018, “imprecise use of race and ethnicity data as population descriptors in genomics research has the potential to miscommunicate the complex relationships among an individual’s social identity, ancestry, socioeconomic status, and health, while also perpetuating misguided notions that discrete genetic groups exist.”1 More precise biologic markers are now available or potentially discoverable that have the potential to more accurately reflect genetic variants (e.g., APOL1 testing) to guide the design of clinical tools in our field and others. As we continue to make progress in the identification of biologic markers, it is our expectation that the imprecise and potentially harmful2 use of race as a surrogate for biologic markers or genetic ancestry in clinical tools will discontinue. We are buoyed by recent medical advances that will replace race with more precise biologic markers. By systematically reporting both an eGFR for Black patients and an eGFR for all other patients, we are perpetuating the notion that there is a fundamental difference in organ function between these two populations. We are encouraging healthcare providers to see these two groups as different. We are allowing a subset of the population to be “othered” in a way that could have a profound impact on everything from antibiotic dosing to kidney transplantation. The over 30 million patients with ESRD in this country deserve an equal opportunity for kidney transplantation. We know that an eGFR less than 20 ml/min is a key lab value that allows patients to be eligible for a transplant. The fact that two clinically identical individuals could have different eGFR calculations and therefore different transplant eligibility is not a reality that we can continue to accept. This is particularly important given the disproportionately high number of Black patients who have ESRD and the fact that Black people are given a higher eGFR based on the same serum creatinine in the current system. ASTS believes a few centers have already eliminated the use of the eGFR tool or have replaced it with a race neutral mechanism, while other centers are waiting for an OPTN policy change to formally remove it from their practice. We anticipate the use of a race neutral eGFR would increase listing, improve access, encourage earlier evaluations, and reduce wait times for black and minority patients. With the implementation of a race-neutral eGFR, transplant centers will only need to educate their coordinators and nephrology staff on listing referrals; otherwise the transition would be straightforward. ASTS recommends the OPTN establish standards by which centers provide educational resources for their staff and related health care professionals. Transparency during implementation is key for patients and families. During this phase, we are concerned that variations in centers’ abilities to openly allow patients’ access to the listing process, may impact referral/care patterns and cause staffing and outreach challenges or create delays in waitlisting. Another unintended consequence is that we may have fewer data points to help us distinguish disparities in access because we are not taking race into consideration. Finally, medical formulas should be race neutral, as race is not a biological factor. The field of medicine is not perfect. It has been shaped by the knowledge and understanding of individuals who are not immune to social systems such as racism and prejudice. But as we continue to identify areas within medicine that contain remnants of misguided race-based assumptions, it is our role as providers to eliminate them from clinical practice. The ASTS supports this change. References: 1. Bonham VL, Green ED, Pérez-Stable EJ. Examining How Race, Ethnicity, and Ancestry Data Are Used in Biomedical Research. JAMA. 2018 Oct 16;320(15):1533-1534. doi: 10.1001/jama.2018.13609. PMID: 30264136; PMCID: PMC6640836. 2. Vyas DA, Eisenstein LG, Jones DS. Hidden in Plain Sight - Reconsidering the Use of Race Correction in Clinical Algorithms. N Engl J Med. 2020 Aug 27;383(9):874-882. doi: 10.1056/NEJMms2004740. Epub 2020 Jun 17. PMID: 32853499.

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Association of Organ Procurement Organizations | 09/29/2021

AOPO is in favor of any policy that ensures the equitable allocation of life saving organs to all potential transplant recipients, regardless of their ethnicity. The use of Glomerular Filtration Rate (GFR) is a key tool in the evaluation of when a patient should be placed on the renal transplant waiting list. While there are several methods of measuring a patients GFR, the test utilized should not provide results influenced by the potential recipient’s ethnicity.

American Society of Transplantation | 09/29/2021

The American Society of Transplantation applauds this proposal for clarifying eGFR is not mandated in allocation. The community is recognizing that, though unintentional, the equations that include race have systematically disadvantaged Black patients over time. We do not support the use of a dichotomous race variable to label individuals, as these equations require non-scientific decision-making using multiple unsound assumptions that are not evidence-based. The AST’s Kidney and Pancreas Community of Practice (KPCOP) policy workgroup?(with representation from several Living Donor Community of Practice (LDCOP) members)?had earlier conducted a survey of adult kidney transplant centers in U.S including members of the KPCOP and LDCOP, from December 2020 to Feb 2021?to seek feedback?on?some of the very questions?posed?by?The OPTN Minority Affairs and Kidney Transplantation Committees?in this proposal. A manuscript outlining the survey results?has been accepted for publication by?CJASN and?will be available soon. Please see below the responses to the items on which feedback has been requested based on our survey results:? ? 1. Which method of estimating or measuring GFR is your transplant program currently using? Why?? ????? Respondents represented 57% (124/218) of adult kidney transplant programs and the responding centers conducted 70% of recent kidney transplant volume.? Most (93%) programs use serum creatinine based eGFR for listing candidates.?Twenty-nine percent also used measured 24-hour creatinine clearance (CrCl) in some cases, while only 7% reported using measured GFR in transplant listing practice. We didn’t collect the data on which of the eGFR equations the transplant programs had been using at the time of the survey.?? ? 2. How would using a race-neutral eGFR affect your program?? ? Race-neutral determination of GFR?requires either the?use of cystatin C based GFR calculators, measuring 24-hour urinary creatinine clearance or measuring GFR via?exogenous filtration marker.?Our survey?indicates that?some of?these alternative tests are not universally available. Cystatin C testing was unavailable at?24%?of the responding centers?and another 11% were unsure.??Similar availability patterns were reported for access to measured GFR (mGFR) using exogenous filtration markers such as iothalamate, urinary?iohexol, or 99m Tc-DTPA. Availability of these tests?varied,?with 61.6% of respondents reporting that their institution has capabilities for measuring GFR, while 31.2% did not have access to measured GFR testing and 7.2% were unsure.?? ? Around 15% of responding centers are using creatinine based GFR estimators but have?stopped reporting GFR values for Blacks and non-Blacks separately. Around?37% plan to assign a single value to all individuals (assuming non-Black), 30% plan to report a range from computation with and without a race modifier, and 20% reported a planned transition to cystatin C-based equations.?A majority (94%) of respondents indicated the continued use of current race-based equations for calculating eGFR is inappropriate, with desire for change grounded in concerns for promotion of health-care disparities by current equations and inaccuracies in reporting of race.? ? 3.?What implementation challenges could use of a race-neutral eGFR present for your transplant program?? ? At the?time?of the survey, 39% of represented centers did not plan to remove race from GFR calculators, 46% were planning and 15% of had already done so.?Among institutions that have dropped or are planning to drop race, 37% plan to assign a single value to all individuals (assuming non-Black), 30% plan to report a range from computation with and without a race modifier, and 20% reported a planned transition to cystatin C-based equations.?While only 15% of responding centers have dropped race from?eGFR calculation, there is considerable variability in reporting and use for waitlisting. Such variability may further exacerbate disparities for listing based on a patient’s choice of transplant center to seek care.? ? 4.?What resources could assist in facilitating a smooth transition for your program?? ? Half of respondents prefer to await additional research and consensus guidance?from ASN/NKF Task Force?before adopting changes.?? One-third of the responding programs lacked or were unsure of availability of testing for cystatin C or measured GFR.?? ? 5.?What potential consequences should be considered during this proposal's development?? ? Most respondents (71%) believed that elimination of race would allow more preemptive waitlisting for Black patients, but a similar number (69%) also raised concerns that such an approach could incur harms.?Key reasons for believing current approaches to GFR estimation are not appropriate include concern for unjustifiably treating race as a biological category rather than as a social construct, concern for perpetuating or extending extant healthcare disparities, including among multi-racial individuals with some Black heritage. However, respondents also registered potential harms of dropping race from eGFR calculations, including overdiagnosis of CKD, premature dialysis initiation and diagnosis of allograft failure, and underestimation of kidney function in screening living donor candidates.? Both sides to the argument, keeping or eliminating?the race coefficient in the CKD-EPI eGFR equation?have some?merit. No doubt there are several issues with using race in the eGFR equation, including?reliance on ‘race’ as reported in the?electronic medical?records?with?no distinction of multiracial?individuals. These reflect challenges to the application of the formula at an individual level. However, we do know, as is noted in the proposal, that?compare to?White individuals, Black persons 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, but 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.?In the United States,?OPTN policy mandates that?living kidney donor?programs?perform timed?creatinine clearance or measured GFR?to?assess?donor kidney function. However, if a program uses eGFR to screen?possible?candidates,?Black donors may be inappropriately?excluded, which would aggravate disparities in living donor transplantation for?Blacks.?In summary, there is?a need?to reduce disparities in access to the kidney transplant waiting list.? An alternative may be to encourage or require a cystatin C or other race neutral measure of renal function for transplant referral and for waitlisting.? We suggest the Minority Affairs Committee consider a policy that prohibits the use of race-based methods(1) rather than mandating a specific method or equation for eGFR. 1 Hoenig MP, Mann A, Pavlakis M. Removal of the Black Race coefficient from the estimated glomerular filtration equation improves transplant eligibility for Black patients at a single center. Clinical Transplantation. 2021; in publication

Erin Fisher | 09/28/2021

We often talk about the evidence -practice gap as experts learn about new findings before practitioners. The race discrepancy with eGFR has been well documented and yet it has taken until 2021 for our transplant programs to determine that this discrepancy needs to be addressed. I look forward to calculating eGFR based on a person's health and not on their race. Thank you for bringing this issue to our attention.

Region 10 | 09/28/2021

Comments: Overall, there is strong approval from the region on the direction the workgroup is going. Several commenters support the removal of the race coefficient from eGFR calculation, as it is an outdated factor that is limiting access to transplantation to minority groups. The workgroup should not stop at eGFR, but continue their ongoing scrutiny of the inclusion of race in other metrics that affect transplant access and outcomes, like KDPI. One member asked that the workgroup propose a specific race neutral formula for use by the community, or propose a race neutral and cost efficient method like Cystatin C. While the member supports the use of a race neutral formula, they also highlighted the need for the workgroup to be cognizant of any unintended consequences. At their hospital, they have seen that a race variable equation is beneficial when evaluating Black living donors. If the race coefficient is not allowed moving forward, this could prohibit some Black living donors from being eligible to donate. A more standardized method of measuring true GFR through novel methods is crucial for evaluating potential Black living donors. Another member noted that eGFR is exclusively relevant for preemptive transplant, which is unfortunately not as common as it should be particularly in socially disadvantaged groups. The workgroup should use this proposed change as an opportunity to remind the referring nephrology community to refer their patients when the eGFR drops below 20 mL/min. The member also supports modification to the waiting time for those already on the waitlist that may have had more waiting time if a race neutral formula had been used earlier.

Region 1 | 09/24/2021

The region strongly voiced support of removing the race coefficient in the eGFR calculation. There were many comments about this being important work, and several members mentioned their institutions have already stopped using the race coefficient. One member stated that it might be possible to further level the playing field by allow patients to back date their wait time from an eGFR less than 20 rather than dialysis start, as some patients have better access to care and get referred much earlier to transplant.

American Nephrology Nurses Association (ANNA | 09/23/2021

ANNA supports

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Region 6 | 09/23/2021

Attendees believed using a race-neutral eGFR equation is important to ensure certain populations are not disadvantaged and that the OPTN should have a low tolerance for transplant programs who don’t change their calculation. Two attendees noted their hospitals have eliminated race from their eGFR calculations. An attendee asked these programs for guidance to help other hospitals determine which formula to use. One program responded they simply removed the race variable from their eGFR equation, but noted there could be better formulas.

Region 8 | 09/22/2021

Region 8 generally supported this proposal, with the exception of two members pointing out potential areas to address. Several members stated their support of removing race from eGFR calculations and making the calculations race neutral. A member pointed out that the OPTN is in a position to mandate programs to use a specific formula. He believed that there could be an increase in consistency by mandating formulas. A member asked if the OPTN was looking at other areas of policy where race could be a factor in calculations. A member stated that his institution uses eGFR and cystatin C to determine GFR. He was unsure whether race neutral was an appropriate solution. He thought the goal of reducing disparities was good but inquired whether the bigger issue was with referrals to transplant? The member suggested changing the GFR for African Americans to 23. The member thought that removing race correction will turn down black living donors and believed that eGFR of 20 to obtaining waiting time is arbitrary. He further suggested that to reduce white privilege, waiting time should begin at dialysis to reduce disadvantages from inefficiencies caused by transplant centers. He suggested that Cystatin C based eGFR would be the ideal path forward. A member pointed out that two issues are being confounded in this proposal. He noted that although race is a social construct and not suitable for scientific understanding, the CKD-epi and MDRD equations ARE valid (with the inclusion of race) and have been demonstrated to be more accurate than urine collection for creatinine clearance. He suggested that what is needed is reliable formula(s) without reference to race BEFORE they make such a leap. He cited the need to make a scientific move and that the OPTN should lead the way.

John Maxcy | 09/21/2021

I am a living non-directed kidney donor (Caucasian) who donated to an African American male so I feel I can speak on this subject as a first hand experience. We should absolutely get rid of utilizing the race coefficient when it comes to eGFR. Here is my very simple reasoning. My recipient is a very slim African American male who definitely suffered from an inflated eGFR value because of the race coefficient. He had very little muscle mass, but he had to wait 3 long years before the criteria was met for transplant. The oddest part of all of this is that I am an ultramarathon running Caucasian male who has naturally higher than normal creatinine. I was not eliminated or delayed from being a living donor because of this though. Luckily, I didn't have a race coefficient that would have moved me from the approved donor category to a marginal decision. You cannot take a shotgun approach (race based eGFR coefficient) to a situation (organ transplant) that requires a laser scoped rifle. Minorities already face enough challenges when seeking a transplant, mainly the socioeconomic ones. Please eliminate the race coefficient completely, and give them a fighting chance.

Stephanie L | 09/17/2021

Strongly support. The current system is biased on our African American/Black population is unfair and unjust. While there has been discussion on muscle mass and creatine, one must also think about chronic kidney disease patients and the level of muscle mass on the actual level of creatinine. It's a non-factor. The GFR system needs to be race-neutral in offering the same level of access for all races across the board. I would also be in support and recommend a further discussion on the "20" rule of GFR status and being seen by transplant. More work needs to be done with our minority/racial/ethnic populations and increasing access to transplant, with this being a step in the right direction.

Anonymous | 09/15/2021

Comments: Region 7 was supportive of removing the race coefficient in the eGFR equation. Several attendees expressed that they agreed with this direction and also agreed that the race coefficient should be removed. During the discussion, many regional members agreed and supported removing the race based differentiation and stated that it is limiting and could negatively affect people who are designated as Black/African American. There was also discussion around the creatinine of Black individuals, and that it was believed to be higher based on body mass. One attendee commented that, there was probably determination early on, that it was not something without basis. There is some evidence that muscle mass is higher in African Americans and that muscle has effect on creatinine. However, several attendees agreed that it should be removed, because it would be detrimental for African Americans with lower muscle mass and they would not want them to be penalized for that. Another attendee commented that, there was a study in the 1960s that was based on muscle mass in African Americans that contributed to higher creatinine. Adding that a lot of things have changed over the decades with multiracial candidates and that there has to be a more scientific way of looking at this or getting rid of it all together. Many attendees agreed to get rid of the separation.

Region 9 | 09/14/2021

Region 9 was strongly supportive of removing the inclusion of race in the eGFR equation. Several commented that this was a long overdue change. A member noted that some labs still use a race-based equation, which will need to be addressed when making this change. There was also a comment that non-race-based GFR equations could be used at any time while changes were being made.

Christie Thomas | 09/14/2021

This proposal to remove the race coefficient in creatinine based eGFR is a laudable in that it demonstrates an intent to reduce disparities and inequities that currently exist. However, I ask, is this a solution for the problem? I think not. Do we know whether race corrected eGFR reduces referral or is the real problem delayed referral overall for the socioeconomically disadvantaged and marginalized populations; where Blacks form the largest numeric group. If the reason for the disparity is because referrals are delayed until dialysis starts, then changing the calculation that gets your eGFR to 20 will not meaningfully change referrals. If the goal is to level the playing field here are two easy options: Adjust the creatinine based eGFR threshold for Blacks to 23 (20 x the race coefficient); or encourage or mandate a cystatin C eGFR for all transplant listings since the cystatin C based eGFR is accurate and race neutral. Parenthetically, I should note that the idea that an eGFR of 20 should get you waiting time is completely arbitrary and not supported by science. Here is a simple yet radical idea. Change the threshold to begin accumulating wait time to the start of dialysis. Patients can still be waitlisted at an eGFR of 20; but they will not gain wait time. Referral at an eGFR of 20 gives the transplant center time to process, evaluate and waitlist a candidate, hopefully, before they need to start dialysis. And allowing waitlisting at an eGFR of 20 or less without accumulating waiting time will still allow children, former living donors and the highly sensitized to be transplanted preemptively because their priority does not require waiting time (although it helps). It is worth noting that there is no evidence that preemptive deceased donor transplants are beneficial. (https://pubmed.ncbi.nlm.nih.gov/21272074/;https://pubmed.ncbi.nlm.nih.gov/21155898/; https://pubmed.ncbi.nlm.nih.gov/23371953/; https://onlinelibrary.wiley.com/doi/full/10.1111/ajt.15472). Changing threshold for waiting time to dialysis start time is much more transparent and effective than transplant centers removing race coefficients in their own eGFR calculation. After all, for a patient to get to a transplant center from a referring physician, he/she must be cognizant of the race neutral eGFR that the transplant center is using, to refer that patient to the transplant center at an earlier point. There is little incentive for physicians to refer a patient early and the only mandate for referral comes from CMS after a patient starts chronic dialysis. UNOS/OPTN should not omit the race correction for eGFR for transplant candidates because it will have unintended consequences. If race correction is wrong, then it is wrong for all Blacks that have reason to be registered with UNOS/OPTN. It is not only transplant candidates that have to be considered but living donors also. Removing the race correction will mean that more Black living donors will likely be turned down as donors because their renal function will be thought to be too low. Bottom line: This is a well intentioned but misguided proposal. I have given suggestions for correcting inequities that exist for Blacks. This does not require dismantling what might be the most accurate (albeit flawed) way to estimate GFR using serum creatinine. Let’s be bold. Change the threshold to begin accumulating wait time to the start of dialysis. Removing race correction to creatinine based eGFR is just tinkering at the edges and is a feel-good idea which is not likely to remove disparities.

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Region 3 | 09/10/2021

Region 3 was supportive of removing the race coefficient in the eGFR equation. An attendee commented the ASN/NKF taskforce will presumably be coming out with a race neutral eGFR equation, and added they have announced they have submitted the final recommendations for publication. They went on to note transplant hospitals will be able to use this formula when available. The commenter also stated their institution no longer includes race in the eGFR calculation. Another attendee question how OPTN policy can impact labs that continue to use the separate values that are sent to primary care physicians who wait to refer patients. Another attendee strongly supported race elimination and encouraged replacing race in KDPI as well. A third attendee expressed strong support for the work of the ASN/NKF Taskforce and the Minority Affairs and Kidney Committees. This commenter added that their healthcare system no longer reports African American eGFR within it electronic medical record, and they look forward to the publication of the Taskforce’s recommendation for a new formula.

Region 2 | 09/10/2021

• Comments: Several members of the region voiced their support to stop the use of eGFR formulas that include the black race coefficient. One member noted that there is an urgent need to remove such formulas and the formulas should be more inclusive of non-white patients. Another member voiced support of using a marker like cystatin C, which has less racial bias. They also stated that Sarcopenia needs to be considered as a disparity in end-organ disease. Another member noted that the committee should consider APOL1 determination in risk stratification of donors. Lastly, it was stated that race has an effect on KDPI calculation and it is time for the community to move to a race neutral calculation.

Marcus Simon | 09/09/2021

The current eGFR formula has been severely flawed and discriminatory against African-Americans, or those who self identify as Black, since it has been used. Using this formula has delayed the timing of interventions that could have slowed CKD progression, leading to worse outcomes. It has delayed the time of when African American patients will be referred for transplant and delayed when qualified waiting time will begin for non-dialysis patients. Furthermore, the African American factor of the formula is also built on the belief that African Americans have more muscle mass than Caucasians, which is just simply untrue. While there may be some differences among races that will affect health conditions and how treatment is administered, these differences must be based in fact, not silly beliefs. Lastly, this change has been long overdue. There has been many conversations and studies pointing out the disparities that are present in healthcare, and it is time to actually take some actions instead of just continuing to talk. Removing race from the formula will be a great step in the types of actions needed to make the changes that are needed. Far too many have suffered, and the time has come to do something about it.

Catherine Ryan | 08/30/2021

The original race-based eGFr calculations were based on a small sample size and the unvalidated belief that Black people have higher muscle mass as a whole, and that therefore their creatinine level would be expected to be higher on this basis. Elevated creatinine is present in a higher proportion of African-Americans compared to white Americans, but this is likely a multifactorial association. Factors such as chronic hypertension and "weathering" are likely to play a role. Consider the parallel of racial populations with a high incidence of diabetes mellitus such as Native Americans. We do not change the definition leading to diagnosis of diabetes in these populations. The definition of chronic kidney disease should not change based on the underlying population by race, given the underlying pathophysiology, particularly as race-based eGFR has the unintended consequence of delaying transplant evaluation for Black men and women as their absolute creatinine level must be higher to meet criteria for transplant. I feel that the Organ Procurement and Transplantation Network should not consider race when determining wait times for organs.

Anonymous | 08/30/2021

Region 5 supported the proposal to Reassess Inclusion of Race in eGFR Equation. A member suggested that the committee research if there is a preferred or recommended formula to use in policy. Many members stated that they strongly support the removal of race in the eGFR equation, and that race should not be included in eGFR. A member supported the proposal and brought up whether a substitution of other facts should be considered to ensure equity on the renal transplant waitlist. The member explained this could prevent introducing other potential disparities in vulnerable groups. Further, the member suggested that the OPTN provide education to centers about current options for calculating eGFR. A member supported the proposal and also suggested to use a fractional decrease in the estimated glomerular filtration rate that utilizes the patient as their own baseline, as opposed to a set cut-off of 20, in order to show a decline in renal function.

Anonymous | 08/27/2021

Region 4 was generally supportive of removing the race coefficient in the eGFR equation. Several commenters agreed that the eGFR equation should be the same for all potential candidates. One attendee commented that the eGFR equation should be eliminated altogether and not considered when determining which patients should be listed. They went on to comment that race/ethnicity should not determine an individual’s ability to be listed for a kidney transplant. Another attendee commented that a better job should be done to educate the African American population on how to be proactive about their care. They went on to comment that everyone should be held to the same standard and eGFR or GFR should be the same for each person at all facilities. An attendee commented that they support efforts to improve access to transplant for groups that may have more difficulty getting an organ. They went on to comment that they also support efforts to increase utilization of every available organ. Finally, one attendee commented that patient feedback on these tools would be important to collect and assess.

Robert Brown | 08/21/2021

Certainly, given the inaccuracy of any eGFR formula, we ought to specify the use of one that puts all individuals on an equal footing when it comes to transplant eligibility. I would strongly endorse the use of a non-race based eGFR calculation for transplant purposes.

Eve Kahn | 08/20/2021

Adopting a race neutral formula will be an incredibly important and timely leap forward for the medical profession, extending lifespans for countless people by innumerable years. Kudos to everyone involved in, and everyone supporting, this groundbreaking work.

Anonymous | 08/19/2021

Someones race should never negatively be used in medical consideriation.

Anonymous | 08/17/2021

Artificially inflating EGFR which has been debunked in the scientific community and is negativity impacting the wait time for black people with CKD in need of a transplant.

Anonymous | 08/13/2021

After listing to the presentation at the UNOS Region 4 meeting, I'm not quite sure why UNOS does not mandate a race neutral test. This seems to be the most simple solution that would ensure the most rapid solution to level the playing field.

Tonya Bradford | 08/09/2021

I very strongly encourage the removal of race as a factor for calculating eGFR. The inclusion of that factor significantly disadvantages African Americans who would otherwise receive a similar eGFR reading without race being included. Those individuals wait longer to be referred for transplant as a result, which may negatively impact their quality of life given that a transplanted kidney provides for better quality of life than dialysis. African Americans should not be disadvantaged in terms of access to transplantation referral due to receiving an eGFR calculation that does not provide a comparable score to others in similar health circumstances.

Sara Hicklin | 08/06/2021

I strongly encourage removing race from the eGFR calculation. I do not believe that African American body composition (muscle mass) is different from other races. African Americans should not be singled out with an eGFR hat is artificially inflated.