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Genetic Testing to Understand and Address Renal Disease Disparities across the United States (GUARDD-US)

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.

Approximately 6,750 participants of African ancestry, age 18-70, with hypertension that either: 1) do not have diabetes and do not have CKD, or 2) have CKD (with or without diabetes) were randomized for the GUARDD-US study.

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. The population for the PGx substudy were participants from main study (above) who were randomized to Intervention and who test negative for APOL1. Only participants from PGx substudy participating sites were included in this population.