# IGNITE Cost Extension - Admin Supplement

> **NIH NIH U01** · UNIVERSITY OF FLORIDA · 2023 · $1,351,790

## Abstract

Project Summary
The current administrative supplement request is for a 24-month extension with funding to complete the ongoing
IGNITE Network pragmatic clinical trials, GUARDD-US and ADOPT-PGx. The GUARDD-US and ADOPT-PGx,
have been underway since July 2020 and February 2021, respectively. These trials will help 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, exclusively 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 clinical 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. A 24-month extension with funding is
needed due to unanticipated network-wide delays in launching each trial and shutdowns due to COVID-19. The
funding requested in this administrative supplement reflects the trial needs as well as enrollment of 50 additional
participants for the Depression Trial to address recruitment shortfalls by other groups and for the costs
associated with leading analyses and publication costs for 15 secondary manuscripts.

## Key facts

- **NIH application ID:** 10820198
- **Project number:** 3U01HG007269-09S2
- **Recipient organization:** UNIVERSITY OF FLORIDA
- **Principal Investigator:** Larisa Humma Cavallari
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2023
- **Award amount:** $1,351,790
- **Award type:** 3
- **Project period:** 2023-08-01 → 2025-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10820198

## Citation

> US National Institutes of Health, RePORTER application 10820198, IGNITE Cost Extension - Admin Supplement (3U01HG007269-09S2). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10820198. Licensed CC0.

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