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

NCT04191824 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 6789

Last updated 2026-03-25

Study results available
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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

Conditions

Interventions

OTHER

Timing of return of results

Participants will be randomized to immediate versus delayed APOL1 return of results

Sponsors & Collaborators

  • National Human Genome Research Institute (NHGRI)

    collaborator NIH

  • Icahn School of Medicine at Mount Sinai

    collaborator OTHER

  • University of Florida

    collaborator OTHER

  • Indiana University School of Medicine

    collaborator OTHER

  • Vanderbilt University Medical Center

    collaborator OTHER

  • Duke University

    lead OTHER

Principal Investigators

  • Hrishikesh Chakraborty, DrPH · Duke University

  • Carol Horowitz, MD · Icahn School of Medicine at Mount Sinai

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-07-10
Primary Completion
2024-04-09
Completion
2024-05-17

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04191824 on ClinicalTrials.gov