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Original ArticleClinical Nephrology
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Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial

David M. Charytan, Jie Yu, Meg J. Jardine, Christopher P. Cannon, Rajiv Agarwal, George Bakris, Tom Greene, Adeera Levin, Carol Pollock, Neil R. Powe, Clare Arnott and Kenneth W. Mahaffey; on behalf of the CREDENCE study investigators
CJASN March 2022, 17 (3) 361-373; DOI: https://doi.org/10.2215/CJN.08980621
David M. Charytan
1Nephrology Division, New York University School of Medicine and New York University Langone Medical Center, New York, New York
2Baim Institute for Clinical Research, Boston, Massachusetts
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Jie Yu
3The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia
4Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
5Department of Cardiology, Peking University Third Hospital, Beijing, China
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Meg J. Jardine
3The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia
6Concord Repatriation General Hospital, Sydney, New South Wales, Australia
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Christopher P. Cannon
2Baim Institute for Clinical Research, Boston, Massachusetts
7Cardiovascular Division, Brigham & Women’s Hospital, Boston, Massachusetts
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Rajiv Agarwal
8Department of Medicine, Indiana University School of Medicine and Veterans Affairs Medical Center, Indianapolis, Indiana
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George Bakris
9Department of Medicine, University of Chicago Medicine, Chicago, Illinois
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Tom Greene
10Division of Biostatistics, Department of Population Health Sciences, University of Utah, Salt Lake City, Utah
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Adeera Levin
11Division of Nephrology, University of British Columbia, Vancouver, British Columbia, Canada
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Carol Pollock
12Kolling Institute of Medical Research, Sydney Medical School, University of Sydney, Royal North Shore Hospital, St. Leonards, New South Wales, Australia
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Neil R. Powe
13Department of Medicine, Priscilla Chan and Mark Zuckerberg San Francisco General Hospital, University of California, San Francisco, California
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Clare Arnott
3The George Institute for Global Health, University of New South Wales Sydney, Sydney, New South Wales, Australia
4Faculty of Medicine, University of New South Wales, Sydney, New South Wales, Australia
14Department of Cardiology, Royal Prince Alfred Hospital, Sydney, New South Wales, Australia
15Sydney Medical School, University of Sydney, Sydney, New South Wales, Australia
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Kenneth W. Mahaffey
16Stanford Center for Clinical Research, Department of Medicine, Stanford University School of Medicine, Stanford, California
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Abstract

Background and objectives The effect of including race in the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation on screening, recruitment, and outcomes of clinical trials is unclear.

Design, setting, participants, & measurements The inclusion and outcomes of participants in the Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE) trial, which randomized individuals with type 2 diabetes and CKD to canagliflozin or placebo, were evaluated after calculating eGFR using the 2009 CKD-EPI creatinine equation with and without a race-specific coefficient or the 2021 CKD-EPI creatinine equation. Treatment effects were estimated using proportional hazards models and piecewise linear mixed effects models for eGFR slope.

Results Of 4401 randomized participants, 2931 (67%) were White participants, 224 (5%) were Black participants, 877 (20%) were Asian participants, and 369 (8%) participants were other race. Among randomized participants, recalculation of screening eGFR using the 2009 equation without a race-specific coefficient had no effect on the likelihood of non-Black participants meeting inclusion criteria but would have excluded 22 (10%) randomized Black participants for eGFR<30 ml/min per 1.73 m2. Recalculation with the 2021 equation would have excluded eight (4%) Black participants for low eGFR and one (0.4%) Black participant for eGFR≥90 ml/min per 1.73 m2, whereas 30 (0.7%) and 300 (7%) non-Black participants would have been excluded for low and high eGFR, respectively. A high proportion (eight of 22; 36%) of end points in Black participants occurred in individuals who would have been excluded following recalculation using the race-free 2009 equation but not when recalculated with the 2021 equation (one of eight; 13%). Cardiovascular and kidney treatment effects remained consistent across eGFR categories following recalculation with either equation. Changes in estimated treatment effects on eGFR slope were modest but were qualitatively larger following recalculation using the 2021 equation. However, the effect of canagliflozin on chronic change in eGFR was attenuated by 7% among Black participants and increased 6% in non-Black participants.

Conclusions In the CREDENCE trial, eGFR recalculation without the race-specific coefficient had small but potentially important effects on event rates and the relative proportion of Black participants without substantially changing efficacy estimates.

Clinical Trial registry name and registration number: Canagliflozin and Renal Events in Diabetes with Established Nephropathy Clinical Evaluation (CREDENCE), NCT02065791

  • canagliflozin
  • estimated glomerular filtration rate (eGFR)
  • clinical trial
  • diabetes mellitus
  • chronic kidney disease
  • race
  • disparity
  • Received June 30, 2021.
  • Accepted January 11, 2022.
  • Copyright © 2022 by the American Society of Nephrology
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Clinical Journal of the American Society of Nephrology: 17 (3)
Clinical Journal of the American Society of Nephrology
Vol. 17, Issue 3
March 2022
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Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial
David M. Charytan, Jie Yu, Meg J. Jardine, Christopher P. Cannon, Rajiv Agarwal, George Bakris, Tom Greene, Adeera Levin, Carol Pollock, Neil R. Powe, Clare Arnott, Kenneth W. Mahaffey
CJASN Mar 2022, 17 (3) 361-373; DOI: 10.2215/CJN.08980621

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Potential Effects of Elimination of the Black Race Coefficient in eGFR Calculations in the CREDENCE Trial
David M. Charytan, Jie Yu, Meg J. Jardine, Christopher P. Cannon, Rajiv Agarwal, George Bakris, Tom Greene, Adeera Levin, Carol Pollock, Neil R. Powe, Clare Arnott, Kenneth W. Mahaffey
CJASN Mar 2022, 17 (3) 361-373; DOI: 10.2215/CJN.08980621
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Keywords

  • canagliflozin
  • estimated glomerular filtration rate (eGFR)
  • clinical trial
  • diabetes mellitus
  • chronic kidney disease
  • race
  • disparity

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