NCT04191824Completed
Genetic Testing to Understand and Address Renal Disease Disparities Across the United States
Source: ClinicalTrials.gov · Last updated 25 Mar 2026
Brief summary (registry, in English)
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
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 6789 (actual)
- First submitted
- 5 Dec 2019
- Start date
- 10 Jul 2020
- Primary completion date
- 9 Apr 2024
- Lead sponsor
- Duke University
- NCT number
- NCT04191824
What you commit to
- Study type: Interventional
- Participants enrolled: 6789
- From 10 Jul 2020 to the primary completion date, 9 Apr 2024
- 14 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0)
- Have had a liver, kidney, or allogeneic bone marrow transplant
- Previously participated in the GUARDD pilot study OR have previously undergone APOL1 testing
Other illness
- Have diabetes, but no CKD.
- Have a terminal illness
- Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility)
- Not a current patient seeing a provider who cares for their hypertension (i.e., family medicine, internal medicine, nephrology, HIV provider, cardiology, hypertension specialists) at a participating site
Lab values
- Have ESRD (eGFR\<15 ml/min)
Other
- Have a left ventricular assist device (LVAD)
- Have patient-reported known pregnancy at time of enrollment
- Too cognitively impaired to provide informed consent and/or complete the study protocol
- Plan to move out of the area within 6 months of enrollment
Who the study is looking for
- Self reported African ancestry
- English Speaking
- Age 18-70 years
- Have diagnosis of hypertension: Diagnosis of hypertension is defined by either:
- ICD10 diagnosis codes (i.e., I10; I11.x; I12.x; I13.x; I16.x) OR
- On active antihypertensive therapy for indication of hypertension OR
- Having systolic blood pressure of 140 mm Hg or greater in at least 2 of the last 3 consecutive recorded values in the EHR OR
- Having hypertension in the patient's medical record problem list
- Have been seen at ≥1 time in past year at a participating primary care site
- Either: 1) do not have diabetes and do not have CKD, or 2) have CKD; Participants with diabetes may be included as long as they also have CKD.
- CKD is defined by either: A) ICD10 codes (i.e., N18.x; E08.22; E09.22; E10.22; E11.22;E13.22 (exclude Z94.0; N18.6; Z99.2)) OR B) Microalbumin/proteinuria level \>30 mg/g for 2 time periods ≥ 3 months. Values taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months of enrollment. OR C) 15 ≤ eGFR ≤ 60 ml/min for 2 time periods ≥ 3 months. GFRs are taken within 12 months of enrollment, unless 2 values are unavailable, then review within 24 months.
- Diabetes is defined by: HbA1c ≥ 6.5 at least one time in the last year OR ICD10 diagnosis codes OR Having diabetes in the patient's medical record problem list.
Age in the registry: 18 years to 70 years · Sex: All · Does not accept healthy volunteers
Sites (14)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Alabama at Birmingham Coordinator of this site? Confirm its status | Birmingham | United States | Unknown status |
| Baylor Research Institute Coordinator of this site? Confirm its status | Dallas | United States | Unknown status |
| University of Florida - Gainesville Coordinator of this site? Confirm its status | Gainesville | United States | Unknown status |
| Eskenazi Health Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| Indiana University Coordinator of this site? Confirm its status | Indianapolis | United States | Unknown status |
| University of Florida - Jacksonville Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Southeastern Healthcare Coordinator of this site? Confirm its status | Lumberton | United States | Unknown status |
| Vanderbilt University Medical Center Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Meharry Medical College Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| Nashville General Hospital Coordinator of this site? Confirm its status | Nashville | United States | Unknown status |
| University Medical Center New Orleans Coordinator of this site? Confirm its status | New Orleans | United States | Unknown status |
| The Institute for Family Health Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| Icahn School of Medicine at Mount Sinai Coordinator of this site? Confirm its status | New York | United States | Unknown status |
| University of Pittsburgh Coordinator of this site? Confirm its status | Pittsburgh | United States | Unknown status |
Related publications
- Genetic Testing for APOL1 in Adults With Hypertension: The GUARDD-US Randomized Clinical Trial.JAMA Netw Open · 2026 · PMID 41784962
This page is information, not medical advice. Discuss any trial with your doctor.