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APOL1 Genetic Testing in African Americans

StatusRecruiting
PhaseNot specified
Started
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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.

Record History

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  1. Notable Primary completion date: Jun 30, 2025 to Jun 30, 2026
    • Study completion date: Jun 30, 2026 to Jun 30, 2027
    • Publications: 5 to 6
    v5
  2. Notable Enrollment target: 350 to 600
    • Primary completion date: Dec 31, 2024 to Jun 30, 2025
    • Study completion date: Dec 31, 2025 to Jun 30, 2026
    • Study description expanded, about 14 words
    v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Study description shortened, about 136 words
    • Publications: 1 to 5
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05656261
Lead Sponsor St. Louis University
Collaborators: Mid-America Transplant
Conditions
(from sponsor)
Genetic Predisposition, Chronic Kidney Diseases, Nephropathy, APOL1 Associated Kidney Disease, Disparities
Related terms Genetic Predisposition to Disease, Kidney Diseases, Renal Insufficiency, Chronic
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov