Limited Competition for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Clinical Centers (U01 Clinical Trial Required)

The National Institutes of Health, through the National Institute of Diabetes and Digestive and Kidney Diseases, is offering a limited competition cooperative agreement to continue support for the Clinical Centers participating in the Caring for OutPatiEnts after Acute Kidney Injury clinical trial. The funding opportunity, Limited Competition for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury Clinical Centers U01 Clinical Trial Required, is a renewal opportunity under activity code U01. The COPE-AKI trial is a randomized controlled trial evaluating a multimodal process of care intervention intended to reduce rehospitalization and morbidity compared with usual care among patients following hospitalization with Stage 2 and 3 acute kidney injury. The continuation is intended to help the consortium fully meet enrollment targets, complete participant follow-up, analyze data, and disseminate study findings. The COPE-AKI consortium includes three Clinical Centers and one Scientific and Data Research Center and is governed by a Steering Committee, with independent monitoring provided by a Data and Safety Monitoring Board. Clinical Centers are responsible for screening and recruiting participants, conducting interventions, obtaining biological samples and clinical information at baseline and during follow-up, and transmitting data and samples to the Scientific and Data Research Center. During the continuation period, Clinical Centers are expected to collaborate with the Scientific and Data Research Center to complete the trial according to the approved protocol. Applicants should budget for in-person Steering Committee meetings every year, or more frequently if needed. Awardees must also comply with consortium policies, applicable NIH requirements, and data and biological sample sharing expectations. NIDDK intends to commit 1.85 million dollars in direct costs in fiscal year 2027 to fund approximately three awards. Application budgets are not limited to a specified amount but must reflect the actual needs of the proposed project. The maximum project period is three years. The opportunity does not require cost sharing. NIH funding restrictions, cost principles, and other requirements apply, and pre-award costs are allowable only as provided under the NIH Grants Policy Statement. Clinical Center applications are expected to include a Data and Resource Biological Sample Sharing Plan, and a Data Management and Sharing Plan is required for NIH-funded research that will generate scientific data. Eligibility is highly restricted because this is a limited competition. Only current recipients under RFA-DK-20-011 are eligible to apply. More specifically, eligibility is limited to institutions that are the principal employer of the Program Director or Principal Investigator of the original COPE-AKI Participating Clinical Centers and the COPE-AKI Scientific Data Research Center. Non-domestic organizations, non-domestic components of United States organizations, and foreign components are not eligible. Only one application per institution is permitted. Program Directors and Principal Investigators must possess the skills, knowledge, and resources necessary to conduct the research. Applicant organizations must maintain required registrations, including SAM, eRA Commons, and Grants.gov, and Program Directors and Principal Investigators must have eRA Commons accounts and valid ORCID registrations. Applications must be submitted electronically using an authorized NIH submission route, including NIH ASSIST, Grants.gov Workspace, or an institutional system-to-system solution. Paper applications are not accepted. Applicants must follow the Research instructions in the NIH How to Apply Application Guide and all program-specific instructions in the funding opportunity. Required application materials include applicable SF424 Research and Related forms, budget materials, the PHS 398 Research Plan, human subjects and clinical trials information, and other applicable NIH forms. The Research Strategy must address the significance and need for continuation, the clinical trial question and methodology, study progress and recruitment, plans to meet enrollment and retention targets, intervention fidelity, data quality and completeness, participant confidentiality and safety, staff training, Clinical Center team expertise, implementation capability, and responsibilities within the multicenter collaboration. Applications will undergo NIH scientific peer review. Reviewers will consider the importance of the research, including significance and innovation; rigor and feasibility, including the scientific approach, recruitment, retention, enrollment, timeline, and milestones; and investigator expertise and institutional resources. Specific attention will be given to whether participant recruitment and retention will be optimized to meet trial targets. Applications may also be reviewed for human subjects protections, biohazards, renewal progress, budget, and period of support as applicable. Recommended applications receive a second level of review by the National Diabetes and Digestive and Kidney Diseases Advisory Council. Funding decisions consider scientific and technical merit, availability of funds, and relevance to program priorities. The opportunity was posted August 31, 2026. The earliest submission date is October 6, 2026, and renewal applications are due November 6, 2026, by 5:00 PM local time of the applicant organization. No separate letter of intent, concept paper, or other pre-application gating deadline is identified. Scientific merit review is anticipated in March 2027, Advisory Council review in May 2027, and the earliest project start date is July 2027. The opportunity expires November 7, 2026. Scientific and research questions may be directed to the NIDDK Division of Kidney, Urologic, and Hematologic Diseases at NIDDK_KUH@nih.gov. Grants management questions may be directed to NIDDKGMBManagementTeam@niddk.nih.gov. No telephone number or named individual is provided for these contacts.

Demonstrate clear and feasible plans to meet participant recruitment and retention targets. Document study progress and standardized recruitment, retention, and intervention fidelity data. Provide rigorous methodology, appropriate statistical analysis, and achievable timelines and milestones. Explain how intervention fidelity and data quality and completeness will be maximized. Demonstrate the Clinical Center team's expertise and ability to implement the protocol and collaborate effectively with the Scientific and Data Research Center. Follow NIH and program-specific application instructions strictly because noncompliant applications may not be reviewed.