N/A N=1,874 Randomized Treatment

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

Chronic Kidney Disease · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT06748040 ↗

Enrolled (actual)

1,874

Serious AEs

—

Results posted

Apr 2025

Primary outcome: Primary: Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Negative Participants — -3.7; -3.1 mmHg — p=0.4852

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Timing of return of results (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Duke University
Primary completion: Apr 2024

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Negative Participants	-3.7; -3.1	0.4852

Summary

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.

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT06748040). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.