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NCT05656261 · ClinicalTrials.gov registry record
APOL1 Genetic Testing in African Americans
A clinical trial of Chronic Kidney Diseases and Genetic Predisposition, sponsored by St. Louis University.
- Recruiting
- Registry status
- 600
- Enrollment target
- 1
- Study location
NCT05656261: Recruiting study of Chronic Kidney Diseases and Genetic Predisposition, sponsored by St. Louis University.
NCT05656261 is a study of Chronic Kidney Diseases and Genetic Predisposition that is actively recruiting participants, run by St. Louis University. The registered enrollment target is 600 participants, above the 437-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (37% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05656261, a study of Chronic Kidney Diseases and Genetic Predisposition, is actively recruiting participants, sponsored by St. Louis University.
- RECRUITING
- Registry status
- 600 participants
- Enrollment target
- 1
- Study location
Study 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.
Primary Outcome
To assess the frequency and sociodemographic/clinical correlates of APOL1 renal risk variants in a local urban population of Black patients seen in Nephrology, Hypertension, Internal/Family Medicine clinics, or University Hospital.
Conditions Studied
Interventions
- GENETIC Assessment of the frequency of APOL-1 renal risk variant in the black population, and evaluating their attitudes about genetic testing and APOL1 genotype via self-administered surveys
Study Locations (1)
Missouri
- SSM Health Saint Louis University Hospital - St Louis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 600 participants |
| Start Date | 2019-01-24 |
| Est. Completion | 2027-06-30 |
What NCT05656261 shows while recruiting
NCT05656261 is an observational study that tracks outcomes without assigning an intervention. The registered 600 participants enrollment target is mid-sized for trials with a published cap, above the 437-participant average among 73 other Chronic Kidney Diseases trials with a reported enrollment target (37% higher).
The record links to 5 conditions, with Chronic Kidney Diseases appearing as the primary indexed condition, and to 1 intervention - of which Assessment of the frequency of APOL-1 renal risk variant in the black population, and evaluating their attitudes about genetic testing and APOL1 genotype via self-administered surveys is the first listed.
NCT05656261 reports a single indexed study location in Missouri.
Frequently Asked Questions
What is clinical trial NCT05656261 about?
NCT05656261 is a clinical study titled "APOL1 Genetic Testing in African Americans". 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 applie...
What is the current status of trial NCT05656261?
This trial is currently recruiting. The enrollment target is 600 participants. The study started on 2019-01-24. Estimated completion is 2027-06-30.
What conditions does trial NCT05656261 study?
This clinical trial studies the following conditions: Chronic Kidney Diseases, Genetic Predisposition, Nephropathy, Disparities, APOL1 Associated Kidney Disease.
What interventions are being tested in trial NCT05656261?
The interventions under investigation include: Assessment of the frequency of APOL-1 renal risk variant in the black population, and evaluating their attitudes about genetic testing and APOL1 genotype via self-administered surveys (GENETIC).
Who is sponsoring clinical trial NCT05656261?
This trial is sponsored by St. Louis University, which has 107 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05656261 being conducted?
This trial has 1 study location across Missouri. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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Where NCT05656261's enrollment target sits among peer trials
600 11th of 73 higher than 61 of 73 other Chronic Kidney Diseases trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Chronic Kidney Diseases trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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