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

Completed · Not applicable

Conditions studied: Chronic Kidney Disease, Hypertension

In brief

This is a substudy of GUARDD-US (Genetic testing to Understand and Address Renal Disease Disparities across the United States, NCT04191824). Its primary purpose is to determine the effect of knowledge of genetic test results that predict efficacy of various antihypertensive medications on change in SBP (systolic blood pressure) from baseline to 3 months in APOL1 (apolipoprotein L1) negative individuals at participating sites.

Key facts

Study ID

NCT06748040

Run by

Duke University

People needed

1874

Starts

2020-07-10

Expected to finish

2024-05-17

Last updated by the study team

2025-06-17

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
• Icahn School of Medicine at Mount Sinai — New York, New York, United States
• The Institute for Family Health — New York, New York, United States
• University of Pittsburgh — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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