Pranav Garimella, MBBS, MPH, is chief medical officer of the American Kidney Fund.

Pranav Garimella, MBBS, MPH

OPTN Policy Gave Back Time, Increased Transplants for Black Kidney Candidates So Why Have Rates Plateaued?

national policy restored waitlisting time and saw an increase in 5.3 transplants per 1000 listings

 for Black kidney transplant candidates marginalized by race-based kidney function equations for decades.

New data from the Organ Procurement and Transplantation Network (OPTN) pointed out that transplant rates have begun to decline again, with experts suggesting structural barriers remain a looming challenge in getting historically marginalized patients onto transplant lists.

“The numbers for a long period of time have been stable, and we see this fight between 2023 and 2024 and over the last two years, once again, there has been a flattening of that curve, and that's because what the policy did was to repay a historical debt of inequity, and that has now been restored,” Pranav Garimella, MBBS, MPH, Chief Medical Officer of the American Kidney Fund and an associate professor of medicine at UC San Diego, told HCPLive. “The question now remains, how do we take this forward and improve access to transplantation for people who have historically been marginalized?”

The history of race-based GFR involves distinct values for patients who identified as black compared to other races. These were based on studies published in the 1990s, which found increased serum creatinine levels in black participants, which they attributed to increased average muscle mass, a historic clinical misconception and stereotype. As a result, race-based GFR equations systematically assigned a ~16–18% higher eGFR value to these patients, leading to an underestimation in the severity of kidney disease, thereby delaying treatment at crucial intervention windows.

In 2021, the National Kidney Foundation and American Society of Nephrology recommended the 2021 CKD-EPI Creatinine Equation, a race-free formula using serum creatinine, age, and sex, removing the variable “black” or “non-black”. The OPTN implemented a national policy in 2022, bolstering the CKD-EPI equation to improve accuracy and fairness in kidney care.

As recently as January 2023, the OPTN implemented a second national policy, which required the review and adjustment of waiting times for Black candidates who had been disadvantaged by the previous equation.

Despite the gains made by this national policy, 

barriers to kidney care and transplantation remain for historically marginalized patient populations.

“Even if we provide them with an updated GFR that makes them eligible, there are factors, financial economics, and social determinants that may not allow them to receive a transplant,” Garimella said. “While the policy itself has shown that it can result in meaningfully increased transplant access to patients who get to that transplant list, getting to that transplant list remains the challenge, and again, beyond people who identify as black.”

Another important facet of this data that Garimella points out is the increase in transplants for candidates who identified as Black, which did not reduce transplants from individuals of other races. He emphasizes that correcting this historical injustice does not mean taking away from others.

Editor’s Note: Garimella has relevant disclosures with Otsuka and the PKD Foundation.

Khazanchi R, Fleishman A, Eneanya ND, et al. Wait Time Modifications for Black Transplant Candidates Affected by Race-Based Kidney Function Estimation. 

. Published online September 2026:e260001. doi:

https://doi.org/10.1001/jamainternmed.2026.0001

Uppal P, Benjamin Ira Golden, Panicker A, Khan OA, Burday MJ. The Case Against Race-Based GFR. 

https://doi.org/10.32481/djph.2022.08.014

Charles K, Mary Jane Lewis, Montgomery E, Reid M. The 2021 Chronic Kidney Disease Epidemiology Collaboration Race-Free Estimated Glomerular Filtration Rate Equations in Kidney Disease: Leading the Way in Ending Disparities. 

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New OPTN data shows kidney transplant gains from race-free GFR and restored wait times stall, as structural barriers still limit equitable listing access.

How Rewriting Race-Based GFR Equations Changed Kidney Transplant Access

Implementing wait time modifications for Black transplant candidates who were negatively impacted by race-based GFR equations was associated with an increase in transplant rates, according to new data from a national policy shift.

"Prior to 2021, lab reports typically reported two GFR values, one for people who identified as Black or African American, and another estimate for everyone else," Pranav Garimella, MBBS, MPH, Chief Medical Officer of the American Kidney Fund and an associate professor of medicine at UC San Diego, told HCPLive. "This was based on studies that found that people who identified as Black have higher levels of creatinine in their blood. What ended up happening was that race-based equations systematically assigned a higher GFR value to Black patients."

In 2023, the Organ Procurement and Transplantation Network (OPTN) implemented a national policy to add wait-time modification for Black candidates who were disadvantaged by eGFR equations with racial coefficients. This policy change sought to correct race-based biological assumptions that had informed clinical decision-making for decades.

“The decisive action required all transplant centers to review their wait lists and submit wait time modifications to persons who identified as black,” Garimella said. “This was really a restorative policy to bring back some level of equity to the transplant wait lists.”

For almost 4 decades, clinicians utilized different eGFR algorithms to estimate the kidney function of patients who identified as black compared to those who were white or within other racial groups. Two widely used equations, the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) and the Modification of Diet in Renal Disease Study (MDRD), incorporated 1.159 and 1.210 coefficient factors for black patients, respectively. Ultimately, this led to higher assigned eGFR values for black patients compared to white patients.

The use of higher eGFR values suggested better kidney function in Black individuals than was actually present. This misestimation created barriers to care, including delayed evaluation and specialist referral, ultimately contributing to worse health outcomes. By the time patients presented with kidney failure, delays in referral and evaluation often meant they were listed for transplant later, reducing accrued wait time and delaying transplantation.

To assess the impact of this policy on transplantation rates, study investigators conducted a quasi-experimental study, analyzing an OPTN database of 181,314 adult kidney transplant candidates who were actively waitlisted. This included 56,344 Black candidates (31.1%) and 124,970 candidates of all other racial and ethnic groups, including American Indian/Alaska Native, Asian, Hispanic/Latino, Native Hawaiian/Other Pacific Islander, White, multiracial, and unknown (68.9%).

Among these, 21,119 transplant candidates received wait time modifications, which added a median (IQR; range) of 1.7 (0.9-3.0; 0-21.2) years, and a total of 51,061 person-years of waitlist time. In interrupted time series analyses, among Black candidates, policy implementation was associated with an increase of 5.3 transplants per 1000 listings (95% Confidence Interval [CI], 3.5 to 7.0), with decreasing transplant rates thereafter (−0.10 transplants per 1000 listings per month; 95% CI, −0.17 to −0.03).

Among all other candidates, implementation was associated with no significant change in overall transplant (0.6 transplants per 1000 listings; 95% CI, −1.8 to 0.7) and a parallel decreasing trend thereafter (−0.10 transplants per 1000 listings per month; 95% CI, −0.15 to −0.05). In secondary analyses, policy implementation was associated with increased overall and deceased donor kidney transplantation (DDKT) rates among Black preemptive and postdialysis candidates, no significant changes in living donor kidney transplantation (LDKT) for either group or DDKT for non-Black and/or Hispanic candidates, and a small secular increase in overall transplant rates.

These findings underscore the need for equitable kidney function assessment practices to ensure timely access to evaluation, transplant listing, and ultimately, improved outcomes.

Dinushika Mohottige, Opeyemi Olabisi, L. Ebony Boulware. Use of Race in Kidney Function Estimation: Lessons Learned and the Path Toward Health Justice. 

https://doi.org/10.1146/annurev-med-042921-124419

Schmidt IM, Waikar SS. Separate and Unequal: Race-Based Algorithms and Implications for Nephrology. 

Journal of the American Society of Nephrology

Garimella discusses the history, clinical impact, and rationale for removing race-based GFR from clinical decision-making.

How Rewriting Race-Based GFR Equations Changed Kidney Transplant Access, With Pranav Garimella, MBBS, MPH

Crisis Point: Unmet Needs and New Horizons in Kidney Transplantation

Our mini-docuseries has returned, taking a comprehensive look at public health crises affecting the United States today, with global implications tomorrow. If the crisis point is the moment where a crisis will worsen or begin to get better, the question remains: where are we now?

From Unmet Needs to New Possibilities: The Evolving Future of Kidney Transplantation

For many patients, kidney transplantation offers a chance not just at prolonged survival, but at a life free from the burdens of dialysis. Despite decades of progress, the field continues to grapple with a constellation of unmet needs, including the shortage of available donor kidneys, geographic inequities in access, risks of rejection, and long-term graft attrition, all of which place lasting burdens on both patients and healthcare systems.

Recent years, however, have seen growing momentum and progress. Improvements in diagnostics are enabling more precise prediction of rejection risk and the tailoring of immunosuppression regimens. Evolving perfusion techniques like continuous hypothermic machine perfusion can better preserve organ quality and potentially extend the viable window between donation and transplantation. The safe use of HCV-positive donor kidneys and the emergent promise of xenotransplantation are also expanding the donor pool in ways once considered unlikely.

To fully realize the impact of these advancements, the system must evolve: policies must be modernized, regulatory pathways harmonized, infrastructure expanded, and equity prioritized so that advances reach the patients who need them most. Only through coordinated, system-level change can the promise of these breakthroughs translate into real-world benefit.

With sustained investment in innovation, equitable deployment of new technologies, and collaboration across stakeholders, the future of kidney transplantation looks bright.

Brief descriptions of the speakers featured in this project are provided below:

, chief medical officer of the American Kidney Fund

, senior medical director of transplant diagnostics at Thermo Fisher Scientific Transplant Diagnostics, former director of renal and pancreas transplantation at Houston Methodist J.C. Walter Jr. Transplant Center and surgical director of kidney and pancreas transplantation in the Department of Surgery

, surgical director of kidney and pancreas transplantation at Piedmont Healthcare

, a patient advocate and 3-time kidney transplant recipient, the most recent of which was with an HCV-positive donor kidney

 to see other episodes on improving health equity in eye care, disparities in cardiovascular health, insulin access in the United States, physician burnout across healthcare, and the ongoing obesity crisis.

A trio of experts and a patient advocate discuss unmet needs and recent innovations in kidney transplantation, from xenotransplantation to continuous hypothermic machine perfusion.

Xenotransplantation: A New Frontier in Kidney Transplantation, With Pranav Garimella, MBBS, MPH

Renal xenotransplantation has taken remarkable strides in 2025, transforming a long-theoretical concept into a tangible clinical reality with recent advances in genetically modified pig kidneys yielding improved compatibility, stronger early outcomes, and extended graft function.

These milestones, including the launch of the first US Food and Drug Administration (FDA)-approved clinical trials, signal a turning point that could reshape the future of kidney transplantation, potentially easing organ shortages and offering new hope to patients who cannot access a human donor kidney.

“Xenotransplantation is perhaps the most exciting frontier in kidney transplant that we've seen, and although it's not new, it's been around for a long time, this is the first time we've seen substantial improvements in patient outcomes and substantial longevity in these xenotransplanted kidneys,” Pranav Garimella, MBBS, MPH, Chief Medical Officer of the American Kidney Fund and an associate professor of medicine at UC San Diego, told 

According to data from the Organ Procurement and Transplantation Network, more than 100,000 people in the US are currently on the national transplant waitlist, with another person added every 8 minutes. In 2023, more than 27,000 kidney transplants were performed, and nearly 90,000 people are still seeking a kidney transplant as of September 2024. With the number of patients seeking a transplant far exceeding the number of donor kidneys available, the US currently faces a major public health crisis.

On February 3, 2025, the FDA made history when it cleared United Therapeutics’ Investigational New Drug application to initiate a clinical study of the company’s investigational UKidney™ derived from a 10 gene-edited source pig, representing the first-ever clinical trial of a xenokidney.

Most recently, the Agency cleared an Investigational New Drug application from eGenesis to initiate a clinical trial evaluating EGEN-2784, a genetically engineered porcine-derived kidney, in patients with end-stage kidney disease who are ≥ 50 years of age, dialysis-dependent, and on the kidney transplant waitlist.

On January 25, 2025, Tim Andrews, 67, received an EGEN-2784 kidney at Massachusetts General Hospital in the institution’s second successful transplant of a genetically edited pig kidney into a living recipient. He has now surpassed 7 months post-transplant, making him the world’s longest-living recipient of a genetically engineered porcine-derived organ.

“I still think xenotransplantation is a bridge,” Garimella said, citing a current lack of knowledge about how long these kidneys will last and what risks might come with the use of these genetically modified organs. “I'm really hopeful. A lot of patients are unable to get kidneys from humans. They can't wait that long, and this would be a fantastic opportunity to get them off dialysis, which significantly impairs quality of life and their ability to do things that they would want.”

Editors’ note: Garimella has relevant disclosures with Otsuka and the PKD Foundation.

HRSA. Organ Donation Statistics. October 2024. Accessed September 11, 2025. 

https://www.organdonor.gov/learn/organ-donation-statistics

Brooks A. FDA Clears First Xenotransplant Trial for Gene-Edited Kidneys. HCPLive. February 3, 2025. Accessed September 11, 2025. 

https://www.hcplive.com/view/fda-clears-first-xenotransplant-trial-gene-edited-kidneys

Brooks A. FDA Clears IND Application for EGEN-2784, a Genetically Engineered Pig Kidney, for ESKD. HCPLive. September 8, 2025. Accessed September 11, 2025. 

https://www.hcplive.com/view/fda-clears-ind-application-for-egen-2784-a-genetically-engineered-pig-kidney-for-eskd

Garimella describes recent progress in renal xenotransplantation, uncertainties that still need to be addressed, and how he sees it impacting the field moving forward.

Pranav Garimella, MBBS, MPH

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