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NCT04191824 · ClinicalTrials.gov registry record · NA
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
A NA study, sponsored by Duke University.
- Completed
- Registry status
- NA
- Development phase
- 6,789
- Enrollment target
NCT04191824 is a NA study that has completed, run by Duke University. The registered enrollment target is 6,789 participants.
The verdict
NCT04191824, a NA study, has completed, sponsored by Duke University.
- COMPLETED
- Registry status
- NA
- Development phase
- 6,789 participants
- Enrollment target
Study Summary
GUARDD-US is a prospective, multicenter, unblinded, two arm randomized pragmatic clinical trial. Participants will be randomized in a 1:1 ratio to immediate APOL1 gene testing and return of results (ROR) to participant and provider (Intervention arm) versus delayed APOL1 gene testing and ROR to participant and provider (Control arm). The main study will compare outcomes between APOL1 positive participants in the Intervention arm (i.e., early knowledge of APOL1 status) to APOL1 positive participants in the Control arm (i.e., delayed knowledge of APOL1 status). Participants that are APOL1 negative in the Intervention and Control groups will not be included in the main study analyses. GUARDD-US also includes a substudy to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP from baseline to 3 months in APOL1 negative individuals at participating sites. This substudy is listed separately on clinicaltrials.gov as NCT06748040 and Unique Protocol ID - PRO00102997\_A
Interventions
- OTHER Timing of return of results
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 6,789 participants |
| Start Date | 2020-07-10 |
| Est. Completion | 2024-05-17 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04191824
The ClinicalTrials.gov registry entry for NCT04191824 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 6,789 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Duke University, which has 1,725 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Timing of return of results is the first listed.
NCT04191824 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04191824 about?
NCT04191824 is a clinical study titled "Genetic Testing to Understand and Address Renal Disease Disparities Across the United States". GUARDD-US is a prospective, multicenter, unblinded, two arm randomized pragmatic clinical trial. Participants will be randomized in a 1:1 ratio to immediate APOL1 gene testing and return of results (ROR) to participant and provider (Intervention arm) versus delayed APOL1 gene testing and ROR to part...
What is the current status of trial NCT04191824?
This trial is currently completed. It is a NA study. The enrollment target is 6,789 participants. The study started on 2020-07-10. Estimated completion is 2024-05-17.
What interventions are being tested in trial NCT04191824?
The interventions under investigation include: Timing of return of results (OTHER).
Who is sponsoring clinical trial NCT04191824?
This trial is sponsored by Duke University, which has 1,725 total clinical trials registered on ClinicalTrials.gov.
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