Genetic Testing to Understand and Address Renal Disease Disparities Across the United States

Completed · Not applicable

Conditions studied: Chronic Kidney Disease, Hypertension

In brief

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

Key facts

Study ID

NCT04191824

Run by

Duke University

People needed

6789

Starts

2020-07-10

Expected to finish

2024-05-17

Last updated by the study team

2026-03-25

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Have diabetes, but no CKD.
• Are currently on dialysis (ICD 10 codes N18.6, Z99.2 and Z94.0)
• Have ESRD (eGFR<15 ml/min)
• Have a left ventricular assist device (LVAD)
• Have a terminal illness
• Have patient-reported known pregnancy at time of enrollment
• Have had a liver, kidney, or allogeneic bone marrow transplant
• Too cognitively impaired to provide informed consent and/or complete the study protocol
• Institutionalized or too ill to participate (i.e. incarcerated, psychiatric or nursing home facility)
• Plan to move out of the area within 6 months of enrollment
• 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
• Previously participated in the GUARDD pilot study OR have previously undergone APOL1 testing

Where it is running

• University of Alabama at Birmingham — Birmingham, Alabama, United States
• University of Florida - Gainesville — Gainesville, Florida, United States
• University of Florida - Jacksonville — Jacksonville, Florida, United States
• Eskenazi Health — Indianapolis, Indiana, United States
• Indiana University — Indianapolis, Indiana, United States
• University Medical Center New Orleans — New Orleans, Louisiana, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The Institute for Family Health — New York, New York, United States
• Southeastern Healthcare — Lumberton, North Carolina, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Meharry Medical College — Nashville, Tennessee, United States
• Nashville General Hospital — Nashville, Tennessee, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Baylor Research Institute — Dallas, Texas, United States

Full record on ClinicalTrials.gov

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