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

The Limited Competition for the Continuation of the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Clinical Centers is a forecasted Notice of Funding Opportunity issued by the National Institutes of Health (NIH) under the U.S. Department of Health and Human Services. The funding mechanism will be a cooperative agreement (U01 Clinical Trial Required), designed to extend the work of the COPE-AKI consortium. The program focuses on advancing post-hospitalization care for patients who have suffered from acute kidney injury (AKI). The clinical trial consortium includes three clinical centers and one scientific and data research center, and this competition specifically supports a three-year continuation to ensure that enrollment targets are achieved, participant follow-up is completed, and critical data analysis and dissemination are carried out. The results are expected to help develop evidence-based strategies that could inform new standards of care for survivors of Stage 2 and 3 AKI, a population for whom no formal post-hospitalization standard of care currently exists. The purpose of this initiative is to generate evidence and insights that will inform clinical practice and health system interventions for patients discharged after AKI. Given the lack of standardized approaches for these patients, the outcomes of the COPE-AKI study are anticipated to address a significant gap in nephrology and critical care, with long-term implications for reducing morbidity and improving survival outcomes. The extension will allow for the consortium to complete patient recruitment and follow-up while ensuring robust analysis of data across participating centers. The scope of funding is limited competition, meaning only designated eligible organizations may apply. Applicants must fall within defined categories including higher education institutions, governments at various levels, nonprofits, tribal organizations, for-profit entities, and other eligible organizations. This ensures that participation is broad but remains restricted to those with the necessary infrastructure and expertise to conduct clinical trials of this scale. Foreign institutions, U.S. territories, federal agencies, and community-based organizations are also eligible, as explicitly noted. Importantly, the funding is discretionary and cooperative in nature, with NIH playing a direct role in oversight and collaboration. The estimated total program funding is $2,500,000, and approximately three awards are expected. While no cost-sharing or matching requirement applies, award amounts for individual applicants have not been specified in terms of a ceiling or floor, meaning applicants must plan budgets in alignment with project requirements and NIH guidance. Funds will primarily be directed toward operational support of the clinical trial, including participant follow-up, data collection and analysis, and dissemination of findings. The timeline for this grant follows a structured schedule. The forecasted post date is April 1, 2026, with applications due by July 1, 2026. Awards are expected to be made on January 1, 2027, with projects beginning on February 1, 2027. This provides applicants sufficient lead time to prepare proposals and align institutional resources. Because this is a forecasted opportunity, potential applicants should monitor for official announcements and confirm dates when the funding opportunity is formally posted. The program is expected to be non-recurring beyond this specific three-year extension. Applications will undergo NIH’s peer review process, and only those deemed meritorious will be funded. As with all NIH opportunities, applicants must comply with submission requirements through Grants.gov and ensure that institutional registrations (eRA Commons, SAM.gov, Grants.gov) are complete before applying. No pre-application deadlines, such as Letters of Intent, have been identified in the forecast. The main submission will be the full application by the posted deadline. For inquiries regarding this funding opportunity, the NIH contact is Ivonne Schulman, reachable at ivonne.schulman@nih.gov or by phone at 301-435-3350. Applicants are encouraged to direct scientific, programmatic, or technical questions to the contact provided once the full NOFO is released. Interested organizations should carefully review eligibility and prepare to engage with NIH guidance to maximize competitiveness when the application window opens.