NCT06748040

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,874 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

GUARDD-US includes a substudy that randomizes participants in the Intervention arm who are from the PGx substudy participating sites and who test negative for APOL1 to PGx Intervention (i.e., immediate PGx ROR) and PGx Control (i.e., delayed PGx ROR) in a 1:1 ratio. This substudy will compare outcomes between participants in the PGx Control group and the PGx Intervention group. New data show that genetic differences may cause patients to respond differently antihypertensive medication therapy. Pharmacogenomics may help guide initial or add-on antihypertensive therapy management. However, the impact of PGx testing on BP has not been studied in clinical trials among general or African ancestry populations. Population for PGx Substudy: Participants from Randomized Population who are randomized to Intervention and who test negative for APOL1. Only participants from PGx-substudy participating sites are included in this population. Substudy Analyses: Major primary endpoint analyses conducted for the APOL1 main study will be repeated for the PGx substudy focusing on differences in outcomes between APOL1 negative individuals with immediate PGx ROR (PGx Intervention) and APOL1 negative individuals with delayed PGx ROR (PGx Control).

Conditions

• Chronic Kidney Disease
• Hypertension

Interventions

Type	Name	Description
OTHER	Timing of return of results	Participants will be randomized to immediate versus delayed return of PGx results.

Timeline

• Start date: 2020-07-10
• Primary completion: 2024-04-09
• Completion: 2024-05-17
• First posted: 2024-12-24
• Last updated: 2025-06-17
• Results posted: 2025-04-30

Locations

8 sites across 1 country: United States