Single Source Renewal for the Continuation of the Liver Cirrhosis Network: Scientific and Data Coordination Center (U24 Clinical Trial Optional)

The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a component of the National Institutes of Health (NIH) within the U.S. Department of Health and Human Services, is offering a single-source renewal opportunity for the Scientific and Data Coordination Center (SDCC) for the Liver Cirrhosis Network (LCN). This funding opportunity, released under the activity code U24 for Resource-Related Research Projects – Cooperative Agreements, is aimed at supporting the continuation of scientific services and data coordination for the LCN, an NIH-funded research initiative that addresses the public health burden posed by liver cirrhosis in the United States. Only Northwestern University, the current SDCC awardee under the predecessor RFA-DK-20-004, is eligible to apply. The funding opportunity number is RFA-DK-26-309, and it is a reissue specifically intended to maintain the scientific integrity and continuity of this critical research network. The Liver Cirrhosis Network is a multidisciplinary, cooperative research initiative designed to investigate the natural history, complications, and potential treatments for liver cirrhosis arising from diverse etiologies including viral infections (hepatitis B, C, and D), genetic conditions (Wilson disease, hemochromatosis), metabolic causes (nonalcoholic steatohepatitis, now referred to as metabolic dysfunction associated steatohepatitis or MASH), autoimmune diseases, and toxic exposures such as chronic alcohol consumption or medication-induced liver injury. Cirrhosis is the final pathway for many chronic liver conditions and is associated with serious complications such as portal hypertension, gastrointestinal bleeding, liver failure, and hepatocellular carcinoma. Despite advances in treatment for underlying liver diseases, cirrhosis remains a major cause of mortality in the U.S., with limited treatment options beyond liver transplantation, which is not accessible for most patients due to eligibility, availability, or socio-economic barriers. The NIDDK established the Liver Cirrhosis Network to advance understanding through two primary initiatives: the LCN Cohort Study (NCT05740358), a prospective observational study focused on the natural history of compensated cirrhosis, and the LCN RESCU Study (NCT05832229), a randomized clinical trial assessing the efficacy and safety of rosuvastatin in this population. This renewal aims to ensure continued oversight, data integrity, coordination, and logistical support for these studies. The SDCC is responsible for statistical design and analysis, centralized IRB coordination, data quality assurance, biospecimen management, and dissemination of findings. In addition, it plays a central role in committee support, logistics, regulatory compliance, and scientific collaboration management, including support for Steering Committee activities and interaction with the NIDDK-appointed Data and Safety Monitoring Board (DSMB). Under the cooperative agreement mechanism, the NIH will maintain substantial involvement with the awardee throughout the project period, including participation in protocol development, performance monitoring, and data review. A Steering Committee comprising representatives from the Clinical Centers, SDCC, and NIH will govern the network. Subcommittees and working groups will oversee critical components such as publications, protocols, biospecimen usage, and safety monitoring. The awardee must also comply with NIH and NIDDK policies for human subjects research, data management and sharing, and reporting of clinical trial information through platforms like ClinicalTrials.gov. The funding opportunity opens on January 9, 2026, with application due dates on February 9, 2026, and again on January 27, 2027. All applications must be submitted electronically via NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system platform, and must follow both the NIH’s general application guide and any program-specific instructions provided in the NOFO. Applications must be received by 5:00 PM local time on the due date, and incomplete or non-compliant applications will not be reviewed. While there is no cost-sharing requirement, applicants must adhere to the NIH’s policy and registration protocols, including having an active SAM registration and a valid UEI. The total amount expected to be awarded is $1,850,000 in fiscal year 2026, with one award to be issued. Although the application budget is not capped, proposed budgets must reflect the actual needs of the project. The maximum project period is five years. Evaluation will be based on scientific and technical merit as determined through NIH peer review, as well as programmatic priorities and funding availability. Only meritorious applications will be funded. The earliest anticipated start date for the first award cycle is December 2026.