Limited Competition for the Continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) Clinical Centers (U01 Clinical Trial Required)

Background
The Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN) has been sponsored by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) since 2002, with a focus on clinical studies of fatty liver disease and NASH. The network has enrolled over 4800 adults and children in its databases, amassed a repository of over 700,000 biosamples, and performed numerous imaging studies. The NASH CRN is positioned to yield important new translatable clinical information with the potential to improve clinical management for patients with NASH.

Grant Details
The purpose of this limited competition notice of funding opportunity (NOFO) is to continue the support of the Clinical Sites of the NASH Clinical Research Network (NASH CRN) as they complete active clinical treatment trials and continue to longitudinally gather biospecimens and data of children and adults with nonalcoholic fatty liver disease (NAFLD), including steatosis, steatohepatitis, and cirrhosis.

The specific objectives of the planned renewal of the NASH CRN include:
- Completing enrollment, execution, analysis, and publication of the VEDS clinical trial in adults
- Completing enrollment, execution, analysis, and publication of the network’s prospective database
- Developing and validating non-invasive biomarkers for the diagnosis and staging of NASH
- Advancing understanding of genetic predictors of NASH
- Advancing understanding of the pathogenesis and progression of NASH
- Assessing utility of liver and spleen stiffness measurement in reflecting disease progression
- Studying pediatric environmental exposures in the disease
- Qualifying biomarkers for fatty liver disease
- Enrolling the Vitamin E Dosing Study (VEDS) in adults to determine the minimum effective dose of vitamin E in fatty liver disease.

Eligibility Requirements
Only the currently participating NASH CRN Program Director(s)/Principal Investigator(s) are eligible to apply to this NOFO. Eligible organizations include higher education institutions, nonprofits, for-profit organizations, state/local/tribal governments, federal agencies, U.S. territories/possessions, independent school districts, public housing authorities/Indian housing authorities, Native American tribal organizations.

Period of Performance
The maximum project period is 3 years.

Grant Value
$3 million dollars in FY 2024 to support two related approaches to the continuation of the Nonalcoholic Steatohepatitis Clinical Research Network (NASH CRN), with up to 9 awards expected in FY 2024 and FY2025 in total under these two RFAs. Initial awards will be up to $250,000 direct costs per year.