# UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis

> **NIH NIH U01** · UNIVERSITY OF PENNSYLVANIA · 2021 · $366,272

## Abstract

PROJECT SUMMARY
This is an application for an administrative supplement for the HOPE Consortium Scientific and Data
Research Center (SDRC) at the University of Pennsylvania. The proposed supplement will provide
funding for regulatory activities associated with conducting the HOPE Trial under an Investigational
New Drug application (IND) issued by the US Food and Drug Administration. The HOPE trial is a
randomized controlled clinical trial testing the efficacy of pain coping skills training to reduce pain
interference and opioid use for patients with chronic undergoing long-term hemodialysis. The trial is
also evaluating the acceptability, tolerability, and efficacy of buprenorphine, a partial opioid agonist,
as an alternative to full agonist opioid pain medication for the subset of trial participants using opioids
for management of their pain. The evaluation of buprenorphine in combination with naloxone requires
that the trial be conducted under an IND because buprenorphine/naloxone has marketing approval for
opioid use disorder but not for pain. The SDRC is responsible for the oversight and documentation of
IND-related activities at all of the enrolling sites (currently 14 but likely to expand to include additional
enrolling sites). These activities include, but are not limited to: training of research team members at
all enrolling sites, monitoring regulatory binders at all sites, maintaining up-to-date site-specific normal
ranges for all locally acquired laboratory studies, maintaining investigational product accountability
procedures and documentation, providing all required protocol modifications to the FDA, creating and
maintaining an investigational drug brochure, reporting adverse events on a weekly basis to the
clinical trials regulatory group at the NIDDK (sponsor) and to the FDA in accordance with the timing
requirements, reporting protocol deviations to the FDA, preparing annual reports for the FDA, and
participating in announced or unannounced audits from the University of Pennsylvania Office of
Clinical Research and/or the FDA. The supplement will provide the additional funding required to
carry out these important activities that were not anticipated when the parent grant was awarded.

## Key facts

- **NIH application ID:** 10469886
- **Project number:** 3U01DK123813-01S2
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** Laura M Dember
- **Activity code:** U01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $366,272
- **Award type:** 3
- **Project period:** 2021-09-01 → 2024-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10469886

## Citation

> US National Institutes of Health, RePORTER application 10469886, UPENN Scientific and Data Research Center for the HOPE Consortium to Reduce Pain and Opioid Use in Hemodialysis (3U01DK123813-01S2). Retrieved via AI Analytics 2026-05-28 from https://api.ai-analytics.org/grant/nih/10469886. Licensed CC0.

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