# Genetic testing to Address Renal Disease Disparities Across the U.S. (GUARDD-US) - Administrative Supplement

> **NIH NIH U01** · ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · 2022 · $288,118

## Abstract

Project Summary
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. As part of the
IGNITE II network, we are implementing two prospective randomized pragmatic genotype-guided clinical trials
(GUARDD-US and ADOPT-PGx) to determine the impact of implementing genetic testing on hypertension,
depression, and pain therapies. This administrative supplement request is to extend the GUARDD-US
recruitment timeline and increase enrollment from our Clinical Group by an additional 200 study participants.
 GUARDD-US: 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 found in AAs, increase kidney
failure risk 10-fold. We propose a genotype-guided trial to 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 5435
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:** 10620537
- **Project number:** 3U01HG010248-05S1
- **Recipient organization:** ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
- **Principal Investigator:** Carol R Horowitz
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $288,118
- **Award type:** 3
- **Project period:** 2022-07-27 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10620537

## Citation

> US National Institutes of Health, RePORTER application 10620537, Genetic testing to Address Renal Disease Disparities Across the U.S. (GUARDD-US) - Administrative Supplement (3U01HG010248-05S1). Retrieved via AI Analytics 2026-06-11 from https://api.ai-analytics.org/grant/nih/10620537. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*