NCT05656261 APOL1 Genetic Testing in African Americans
| NCT ID | NCT05656261 |
| Status | Recruiting |
| Phase | — |
| Sponsor | St. Louis University |
| Condition | Genetic Predisposition |
| Study Type | OBSERVATIONAL |
| Enrollment | 600 participants |
| Start Date | 2019-01-24 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 600 participants in total. It began in 2019-01-24 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
Inclusion Criteria: * Ages 18-90 * Self-Identified as Black/African American. Race will be self-identified. Patients of African ancestry who identify as multi-racial are also eligible to participate. Exclusion Criteria: * Cognitively impaired/unable to provide consent * Terminally ill * Renal replacement therapy (RRT), e.g., (but not limited to) hemodialysis, peritoneal dialysis
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05656261 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 90 Years, studying Genetic Predisposition. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05656261 currently recruiting?
Yes, NCT05656261 is actively recruiting participants. Contact the research team at krista.lentine@health.slu.edu for enrollment information.
Where is the NCT05656261 trial being conducted?
This trial is being conducted at St Louis, United States.
Who is sponsoring the NCT05656261 clinical trial?
NCT05656261 is sponsored by St. Louis University. The trial plans to enroll 600 participants.