Use of New 2021 CKD-EPI as an Endpoint in Transplant Trials May Significantly Influence Observations

E. Yanqui¹, H. Hames¹, T. Shi², A. R. Shields¹, E. S. Woodle¹, R. R. Alloway¹

¹University of Cincinnati, Cincinnati, OH, ²CCHMC, Cincinnati, OH

Meeting: 2022 American Transplant Congress

Abstract number: 311

Keywords: African-American, Graft function, Kidney transplantation, Renal function

Topic: Clinical Science » Kidney » 50 - Health Equity and Access

Session Information

Session Name: Health Equity and Access I

Session Type: Rapid Fire Oral Abstract

Date: Monday, June 6, 2022

Session Time: 5:30pm-7:00pm

Presentation Time: 6:20pm-6:30pm

Location: Hynes Ballroom C

*Purpose: GFR equations have recently been modified primarily to avoid disadvantaging black populations. The purpose of this study was to evaluate renal function and the impact of various eGFR equations on endpoint observations from kidney transplant immunosuppression trials.

*Methods: Data from two centers participating in a large patient multicenter randomized clinical trial were used to compare eGFR estimates using CKD-EPI 2009, CKD EPI 2021, and the 6-point MDRD equation and also to evaluate CKD staging and renal function endpoints in a KTx trial that compared CNI free and CNI based regimens with long term observations out to 5 years.

*Results: Results of eGFR calculations for renal function by CKI-EPI 2009, MDRD, and CKI-EPI 2021 were assessed for slope (Figure 1) and Stage 3 CKD (Table 1) in 168 KTx recipients by ITT analysis. Observations comparing black and non-black populations revealed that blacks experienced: 1) a higher rate of Stage 3 CKD when using CKI-EPI 2021 (p=0.0507) (Table 1), 2) a lower 1-month baseline eGFR (Figure 2), 3) numerically worse eGFR decline out to five years (Table 2), and 4) higher CKD staging at all time points (Figure 4a and b) than non-Blacks. Interestingly, blacks experienced a numerically higher eGFR decline than non-blacks in a tacrolimus-based regimen that was not observed with belatacept-based regimens (Table 2 and Figure 3a, 3b). Regression analysis showed baseline 1 month eGFR differences were significantly related to race (P value < 0.0001) and treatment group (P value < 0.0001).

*Conclusions: 1) CKD-EPI influences renal function outcome observations particularly in blacks, 2) Individual endpoints may be influenced significantly by the 2021 CKD-EPI equation, 3) In clinical trials, renal function is best assessed using multiple eGFR endpoints, including CKD staging, 4) Blacks have a lower 1-month eGFR compared to non-blacks independent of immunosuppression. Further research is needed to understand racial differences in 1 month.

To cite this abstract in AMA style:

Yanqui E, Hames H, Shi T, Shields AR, Woodle ES, Alloway RR. Use of New 2021 CKD-EPI as an Endpoint in Transplant Trials May Significantly Influence Observations [abstract]. Am J Transplant. 2022; 22 (suppl 3). https://atcmeetingabstracts.com/abstract/use-of-new-2021-ckd-epi-as-an-endpoint-in-transplant-trials-may-significantly-influence-observations/. Accessed May 7, 2025.

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