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)

Background
The National Institutes of Health (NIH), specifically the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), is issuing a Notice of Funding Opportunity (NOFO) for a Single Source application to continue support for the Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (SDRC).

The COPE-AKI clinical trial consortium aims to address the lack of standard care for patients post-hospitalization with acute kidney injury (AKI), which is associated with high morbidity and mortality. The goal is to complete participant enrollment, follow-up, data analysis, and dissemination of findings to improve clinical management strategies for Stage 2 and 3 AKI survivors.

Grant Details
The SDRC will be responsible for:
1. Completing participant enrollment targets;
2. Conducting participant follow-up;
3. Finalizing data analysis;
4. Disseminating study findings;
5. Collaborating with Clinical Centers (CCs) to ensure scientific integrity and robustness of research design;
6. Providing biostatistical expertise and conducting analyses in conjunction with CC investigators;
7. Managing data quality, storage, and submission to the NIDDK Biorepository;
8. Coordinating recruitment site selection to enhance representation of affected populations;
9. Conducting training and certification of study staff;
10. Preparing manuscripts reporting study findings.

Eligibility Requirements
Only the current recipient under RFA-DK-20-012 is eligible to apply as this is a Single Source application. Non-domestic entities are not eligible.

Period of Performance
The maximum project period is three years, with activities anticipated to commence following successful application review.

Grant Value
NIDDK intends to commit approximately $1.8 million total costs in FY 2026 to fund one award.