Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
Public ClinicalTrials.gov record NCT04191824. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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
Study identification
- NCT ID
- NCT04191824
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Not applicable
- Enrollment
- 6,789 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years to 70 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jul 9, 2020
- Primary completion
- Apr 8, 2024
- Completion
- May 16, 2024
- Last update posted
- Mar 24, 2026
2020 – 2024
United States locations
- U.S. sites
- 14
- U.S. states
- 9
- U.S. cities
- 10
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of Florida - Gainesville | Gainesville | Florida | 32610 | — |
| University of Florida - Jacksonville | Jacksonville | Florida | 32209 | — |
| Eskenazi Health | Indianapolis | Indiana | 46202 | — |
| Indiana University | Indianapolis | Indiana | 46202 | — |
| University Medical Center New Orleans | New Orleans | Louisiana | 70112 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| The Institute for Family Health | New York | New York | 10035 | — |
| Southeastern Healthcare | Lumberton | North Carolina | 28358 | — |
| University of Pittsburgh | Pittsburgh | Pennsylvania | 15261 | — |
| Meharry Medical College | Nashville | Tennessee | 37208 | — |
| Nashville General Hospital | Nashville | Tennessee | 37208 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232 | — |
| Baylor Research Institute | Dallas | Texas | 75210 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04191824, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Mar 24, 2026 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT04191824 live on ClinicalTrials.gov.