# Sparking Advancements in Genomic Medicine

> **NIH NIH U01** · UNIVERSITY OF FLORIDA · 2022 · $750,442

## Abstract

Project Summary
As part of the IGNITE II network, two prospective randomized pragmatic genotype-guided clinical trials,
GUARDD-US and ADOPT-PGx, have been underway since July 2019 and February 2021, respectively. These
trials will help to determine the impact of implementing genetic testing on hypertension, depression, and pain
therapies. 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 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. ADOPT-PGx: Pain and depression are conditions
that impact substantial proportions of the US population. The treatment of acute and chronic pain is challenged
by the difficulty of finding effective therapies while minimizing the risk of adverse effects or opioid addiction. For
depression, there are few clinically relevant predictors of successful treatment, which results in inadequate
therapy for many patients. We propose a prospective randomized pragmatic genotype-guided clinical trial that
tests the effect of genotype-guided therapy in three scenarios of patients: acute post-surgical pain, chronic
pain, and depression. For each scenario, participants will be randomized to genotype-guided drug therapy
versus usual approaches to drug therapy selection. Changes in patient reported outcomes representing pain
and depression control using standard PROMIS scales define the primary endpoints. Secondary analyses
include safety endpoints, changes in overall well-being, and economic impact represented by differences in
healthcare utilization. The current administrative supplement request reflects trial needs for Year 5/9 largely
due to unanticipated network-wide delays with the ADOPT-PGx and GUARDD-US trials and shutdowns due to
COVID-19. In addition, this administrative request reflects the UF Clinical Group’s (CG) enrollment of 100
additional participants for the Acute Pain Trial, bringing UF’s enrollment goal to 850 participants.

## Key facts

- **NIH application ID:** 10629549
- **Project number:** 3U01HG007269-09S1
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Larisa Humma Cavallari
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2022
- **Award amount:** $750,442
- **Award type:** 3
- **Project period:** 2013-06-16 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10629549

## Citation

> US National Institutes of Health, RePORTER application 10629549, Sparking Advancements in Genomic Medicine (3U01HG007269-09S1). Retrieved via AI Analytics 2026-05-21 from https://api.ai-analytics.org/grant/nih/10629549. Licensed CC0.

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