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

This is a Notice of Funding Opportunity (NOFO) for a Limited Competition that will invite application(s) from eligible organization(s) to apply. Please see Section III. Eligibility for additional information. In accordance with NIH standard peer-review processes, the application(s) will be peer-reviewed, and only meritorious application(s) will be considered for funding. This NOFO requests limited competition applications for a 3-year extension of the COPE-AKI clinical trial consortium, which includes three clinical centers (CCs) and one scientific and data research center (SDRC), to fully meet the enrollment targets, complete participant follow-up, and provide resources for data analysis and dissemination of study findings. There is currently no standard of care for patients after hospitalization with acute kidney injury (AKI). Successful completion of the COPE-AKI study will provide key insights that are expected to directly inform improved clinical management strategies and the development of standard of care for Stage 2 and 3 AKI survivors.

Refer to Section III. Eligibility Information in the NOFO for additional information on eligibility.As this NOFO is a Limited Competition, only the current recipients under RFA-DK-20-011 are eligible to apply under this announcement.As this NOFO is a limited competition opportunity, only the institutions that are the principal employer of the Program Director/Principal Investigator of the original COPE-AKI Participating Clinical Centers and the COPE-AKI Scientific Data Research Center are eligible to apply in response to this NOFO.Foreign Organizations/International Collaborations:Non-domestic (non-U.S.) Entities (Foreign Organizations) are not eligible to apply.Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.

The major elements in evaluating proposals include assessments of: (1) The scientific merit and general significance of the proposed study and its objectives; (2) the technical adequacy of the experimental design and approach; (3) the competency of the proposed investigator or group to successfully pursue the project; (4) the adequacy of the available and proposed facilities and resources; (5) the necessity of the budget components requested in relation to the proposed project; and (6) the relevance and importance to announced program objectives. The following criteria will be used in considering the scientific and technical merit of SBIR/STTR Phase I grant applications: (1) The soundness and technical merit of the proposed approach; (2) the qualifications of the proposed principal investigator, supporting staff, and consultants; (3) the technological innovation of the proposed research; (4) the potential of the proposed research for commercial application; (5) the appropriateness of the budget requested; (6) the adequacy and suitability of the facilities and research environment; and (7) where applicable, the adequacy of assurances detailing the proposed means for (a) safeguarding human or animal subjects, and/or (b) protecting against or minimizing any adverse effect on the environment. Phase II grant applications will be reviewed based upon the following criteria: (1) The degree to which the Phase I objectives were met and feasibility demonstrated; (2) the scientific...