Are results from clinical trials in kidney transplant recipients applicable to the real world?

Investigators recently examined the extent to which participants in clinical trials related to kidney transplantation are similar to individuals undergoing transplantation in the United States. The research will be presented at ASN Kidney Week 2023 November 1–5.

The analysis included randomized controlled trials completed between 1990 to 2020 that included adult kidney transplant recipients, involved at least one U.S. center, and had 100 or more participants. For each trial, the inclusion and exclusion criteria were applied to the Scientific Registry of Transplant Recipients (SRTR) to identify patients undergoing transplantation during the trial enrollment period.

The investigators identified 43 trials that met the study inclusion criteria, with a total of 13,780 participants enrolled. After searching each trial's inclusion and exclusion criteria during the trial enrollment period, 32,1779 transplant recipients were identified in the SRTR who were potentially eligible for trial participation.

Trial participants were younger, more likely to be White, and less likely to be Black or Asian. These differences between trial participants and transplant eligible transplant recipients in the U.S. persisted even in more recent trials.

"Concentrated efforts are ongoing to address the need for better participant diversity in clinical trials," said corresponding author Oshorenua Aiyegbusi, MD, of the University of British Columbia, Division of Nephrology, Vancouver, Canada. "Improvement is still needed; our clinical trials should reflect our patients. Our work suggests we ought to review our clinical trial enrollment processes to identify barriers in participation for women and patients of diverse ethnic and racial groups."