Single Source for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (U01 Clinical Trial Required)

The National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases, is offering a single source cooperative agreement to continue the Caring for OutPatiEnts after Acute Kidney Injury Scientific and Data Research Center. The opportunity is a reissue of RFA-DK-20-012 and uses the U01 Research Project Cooperative Agreement activity code. Its purpose is to provide a three-year extension or renewal of the COPE-AKI clinical trial consortium so that enrollment targets can be fully met, participant follow-up can be completed, data can be analyzed, and study findings can be disseminated. The clinical trial addresses the absence of a standard of care for patients following hospitalization with Stage 2 or 3 acute kidney injury and is intended to inform improved clinical management strategies for AKI survivors. The Scientific and Data Research Center is expected to continue ensuring the scientific integrity and robustness of the study design, biostatistics, trial implementation, data quality, analysis, storage, and transfer of study data and biospecimens to the NIDDK Biorepository. Responsibilities include maintaining databases, performing quality control and statistical analyses, coordinating publications, monitoring population characteristics and participant safety, supporting recruitment and retention, coordinating biosample collection and transfer, conducting Steering Committee and Data and Safety Monitoring Board activities, maintaining Consortium websites, and ensuring continuous involvement of patient-participant advisors. The center may also select, train, and implement population-specific recruitment sites to enhance the generalizability of the findings. NIDDK intends to commit approximately 1.8 million dollars in total costs to fund one award. Application budgets are not limited but must reflect the actual needs of the proposed project, and the maximum project period is three years. Budgets may include up to 0.8 million dollars for efforts intended to enhance participant recruitment to reflect the population affected by acute kidney injury and increase the generalizability of trial findings. Those recruitment funds will be restricted until appropriate strategies are developed by the Scientific and Data Research Center in collaboration with NIDDK. Cost sharing is not required. NIH policies regarding allowable costs, pre-award costs, data management and sharing, reporting, and other terms and conditions apply. Eligibility is highly restricted because this is a Single Source opportunity. Only the current recipient under RFA-DK-20-012 is eligible to apply, and only the Program Director or Principal Investigator associated with the original COPE-AKI Scientific Data Research Center selected under that announcement is eligible. Non-U.S. organizations, non-U.S. components of U.S. organizations, and foreign components are not eligible or allowed. Only one application per institution is permitted. Required organizational registrations include SAM, eRA Commons, and Grants.gov, and the same Unique Entity Identifier must be used across applicable registrations and the application. Program Directors and Principal Investigators must have eRA Commons accounts, must be registered with ORCID, and must link a valid ORCID ID to their eRA Commons personal profiles. Applications must follow the Research instructions in the NIH How to Apply Application Guide together with the program-specific requirements in the NOFO. Electronic submission is required, and applicants may use NIH ASSIST, an institutional system-to-system solution, or Grants.gov Workspace, with application status tracked through eRA Commons. The Research Strategy must address the significance and continuation of the study, clinical trial strategy and methodology, statistical analysis, recruitment goals and progress, confidentiality and safety, staff training, Scientific and Data Research Center expertise and responsibilities, collaboration with the Clinical Centers, and applicable recruitment strategies. The application must also address data and biological sample sharing, provide a Data Management and Sharing Plan, and follow applicable human subjects and clinical trial requirements. Applications are evaluated for scientific and technical merit, including the importance of the research, rigor and feasibility of the approach, investigator expertise, institutional resources, human subjects protections where applicable, and whether the proposed budget and period of support are justified and reasonable. The opportunity was posted August 31, 2026, and the earliest submission date is October 9, 2026. The application deadline is November 9, 2026, at 5:00 PM local time of the applicant organization, and the opportunity expires November 10, 2026. Scientific merit review is anticipated in March 2027, Advisory Council review in May 2027, and the earliest project start date is July 2027. The announcement does not state that this single source renewal opportunity will recur. Scientific and research questions may be directed to NIDDK_KUH@nih.gov, while grants management questions may be directed to NIDDKGMBManagementTeam@niddk.nih.gov. Applicants should submit early enough to identify and correct electronic submission errors before the deadline.

Demonstrate the importance of completing the COPE-AKI trial and provide a rigorous, feasible approach supported by appropriate methodology, statistical analyses, sample size justification, recruitment and retention plans, participant protections, data quality procedures, and a realistic timeline. Clearly demonstrate SDRC expertise, successful collaboration with the Clinical Centers, capacity to complete enrollment and follow-up, and appropriate institutional resources. Ensure the requested budget and period of support are fully justified and reasonable, follow all program-specific Research Strategy requirements, and submit early enough to correct electronic submission errors before the deadline.