# Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana.

> **NIH NIH U01** · INDIANA UNIVERSITY INDIANAPOLIS · 2022 · $166,432

## Abstract

The promise of genomic medicine to transform healthcare and improve health will not be fully realized until
discoveries become relevant to and available for use by diverse populations and their clinicians. Chronic
kidney disease (CKD) is associated with hypertension. People with African ancestry (AAs) have the highest
risk of CKD and kidney failure, the highest prevalence of hypertension, and the lowest rate of blood pressure
(BP) control. While this disparity is in part due to social determinants, ancestry has biological underpinnings
and APOL1 high-risk genetic variants, nearly exclusive in AAs, increase kidney failure risk 10-fold. As part of
the IGNITE II network, we will continue to conduct the prospective randomized pragmatic genotype-guided
clinical trial, GUARDD-US, to determine the impact of implementing APOL1 and antihypertensive
pharmacogenomic testing on hypertension control. The trial will determine the effect of early vs. delayed
knowledge of a positive APOL1 genotyping result on 3-month systolic blood pressure (SBP). The trial aims to
recruit African Americans with hypertension, with or without CKD, randomized to immediate versus delayed
return of APOL1 genetic testing. In those who are APOL1 negative, we will also conduct a pilot study to test
the impact of pharmacogenetic (PGx) testing on SBP. Secondary outcomes include 6-month SBP, in CKD
patients, on medications ordered, renal diagnosis and testing patient psycho-behavioral outcomes, cost
effectiveness, and the effect of PGX guided hypertension management on SBP. We expect the successful
results from this clinical trial will provide critical evidence needed to drive the implementation of genomic
medicine across broad demographics of patient populations.

## Key facts

- **NIH application ID:** 10561225
- **Project number:** 3U01HG010245-04S2
- **Recipient organization:** INDIANA UNIVERSITY INDIANAPOLIS
- **Principal Investigator:** Paul Dexter
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $166,432
- **Award type:** 3
- **Project period:** 2022-03-01 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10561225

## Citation

> US National Institutes of Health, RePORTER application 10561225, Implementing genomic medicine through pragmatic trials in diverse and underserved populations across Indiana. (3U01HG010245-04S2). Retrieved via AI Analytics 2026-05-25 from https://api.ai-analytics.org/grant/nih/10561225. Licensed CC0.

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