N/A N=6,754 Randomized Treatment

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

Chronic Kidney Disease · Hypertension

Bottom Line

View on ClinicalTrials.gov: NCT04191824 ↗

Enrolled (actual)

6,754

Serious AEs

—

Results posted

Apr 2025

Primary outcome: Primary: Change in Systolic Blood Pressure From Baseline to 3 Months for APOL1 Positive Participants. — -1.8; -1.5 mmHg — p=0.7769

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 Positive Participants.	-1.8; -1.5	0.7769
SECONDARY Change in Number of Participants With Urine Microalbuminuria/Proteinuria Orders	95; 43	<0.0001 sig
SECONDARY Number of Participants With Documented Order of Microalbuminuria/Proteinuria Tests	302; 264	0.0753
SECONDARY Number of Participants With a Change in Documented Diagnosis for Stage 3 CKD and Above	6; 5	0.8044
SECONDARY Number of Participants With Documented Diagnosis of CKD Stage 3 and Above	83; 103	0.0570
SECONDARY Number of Participants With a Change in Documented Diagnosis for Any Stage CKD	31; 10	0.0012 sig
SECONDARY Number of Participants With Documented Diagnosis of All Stages of CKD	140; 138	0.8483

Summary

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

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 (NCT04191824). 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.