Clinical Trial

APOL1 Genetic Testing in African Americans

Recruiting
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Record status
This record was last updated March 20, 2025 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.
Summary
Recent breakthroughs in medical genetics have discovered that a portion of kidney failure affecting the Black community is mediated by coding variants in a gene called apolipoprotein L1 (APOL1) - and that genetic variants, not race - account for increased risk. For APOL1 genetic testing to be applied in a manner that improves patient care and outcomes, more information is needed regarding associations of genotype with clinical parameters related to kidney health. Further, understanding patient perceptions about knowledge of the results of APOL1 genetic testing, and how that impacts patient engagement with management of hypertension and other renal risk factors, is urgently needed. * In a Phase 1 pilot study, we offered APOL1 genetic testing to Black patients seen in our Hypertension and Nephrology clinics at Saint Louis University, an academic medical center that serves the local urban community, and surveyed patients on attitudes and concerns about APOL1 genetic testing. 144 participants were enrolled in Phase 1. * In the Phase 2 study, we will advance this important work in our community by offering participation to a broader patient base, including patients seen in Internal and Family Medicine clinics, SLU Hospital, as well as to first-degree relatives and spouses of SLUCare participants. This expansion seeks to advance understanding of environment-gene interactions, improve risk prediction, and target management of potentially modifiable risk factors.
Protocol Amendment History 4 amendments
This ClinicalTrials.gov record has been amended 4 times since 2022-12-09; most recent amendment 2025-03-17.
Trial Details
NCT Number NCT05656261
Lead Sponsor St. Louis University
Collaborators: Mid-America Transplant
Conditions Genetic Predisposition, Chronic Kidney Diseases, Nephropathy, APOL1 Associated Kidney Disease, Disparities
Enrollment 600 participants
Start Date 2019-01-24
Primary Completion 2026-06-30 (estimated)
Study Completion 2027-06-30 (estimated)
Updated on ClinicalTrials.gov 2025-03-20