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Abstract: TH-PO1102

Race, Gender, and the Participation Gap: Evaluation of Clinical Trials in Kidney Disease

Session Information

Category: CKD (Non-Dialysis)

  • 1902 CKD (Non-Dialysis): Clinical, Outcomes, and Trials


  • Agarwal, Krishna A., UMass Medical School-Baystate, Springfield, Massachusetts, United States
  • Agarwal, Nayan, University College of Medical Sciences and GTB Hospital, Delhi, New Delhi, India
  • Garimella, Pranav S., University of California, San Diego, California, United States
  • Chopra, Tushar, University of Virginia, Charlottesville, Virginia, United States
  • Wong, Michelle M.Y., University of British Columbia, Vancouver, British Columbia, Canada
  • Malhotra, Rakesh, University of California, San Diego, California, United States

Disparities in kidney disease by race, ethnicity, and sex are well documented. However, the representation of these groups in randomized controlled trials (RCTs) is largely unknown. Here, we aim to determine differences in gender and race participation in kidney disease RCTs.


The electronic database was searched from January 1, 1970 to January 1, 2018, with the following keywords: “kidney disease,” “chronic kidney disease” (CKD), “acute kidney injury” (AKI), “hemodialysis” (HD), “peritoneal dialysis”, “glomerulonephritis” (GN), “kidney stones”, “kidney transplant”, or “polycystic kidney disease” (ADPKD). RCTs that were registered as completed and which reported results were eligible for inclusion. We limited our search to studies which were conducted in United States and published in the English language. Two reviewers independently extracted race and gender data onto standardized extraction forms.


The initial search provided 2436 citations with 339 studies (CKD 109; HD 75; AKI 44; GN 40; Transplant 33; ADPKD 19; Misc. 19) potentially eligible for inclusion. Of the 339 trials (n=102,361, mean age 56±12 years), sex was reported for 98% (n=100,452) of trial participants. Women accounted for 43% of participants overall, with similar percentages in non-dialysis CKD RCTs and dialysis RCTs. Race was reported for 60% (n= 61, 697), of which 78.5% were Caucasians, 15.6 % African American (AA), 3.7% Hispanics, 1.5% Asians, 0.6% American Indians and 0.1% were Native Hawaiian. In HD RCTs, Caucasian (44.9%) and AA (42.0%) were equally represented, and Hispanics accounted for 9.6% of trial participants. Low recruitment of AA (3.2% and 11.6%, respectively) and Hispanics (5.8% and 0.7%, respectively) was observed in both transplant and AKI RCTs.


Our findings suggest that racial minorities, especially AA and Hispanics, and women are less likely to be enrolled in clinical trials. Future studies should focus on addressing the barriers to recruitment of women and minorities in RCTs, in order to achieve representative RCT populations.