Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Clinical Centers (U01 Clinical Trial Required) | RFA DK 20 011

Opportunity Information: Apply for RFA DK 20 011

The Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Clinical Centers opportunity (RFA-DK-20-011) is a National Institutes of Health (NIH) cooperative agreement (U01) focused on improving outcomes for people who survive an episode of acute kidney injury (AKI) after they leave the hospital. The central problem the program is trying to solve is that AKI survivors face substantial long-term risks, including progression to chronic kidney disease (CKD), end-stage kidney disease (ESKD), cardiovascular disease, and higher mortality. Those risks are not evenly distributed; they increase with more severe AKI, longer duration of injury, repeated AKI events, older age, pre-existing CKD, and the presence of other health conditions. Despite how common and serious these downstream complications are, the evidence base for what outpatient follow-up processes and treatments actually prevent kidney decline and related complications remains limited, which creates a gap in care and a missed chance to prevent chronic disease and premature death.

COPE-AKI is structured as a consortium designed to generate that missing evidence by developing and testing interventions in real clinical settings. The consortium is expected to include three to four Clinical Centers (CCs) plus a separate Scientific and Data Research Center (SDRC). Within this structure, the Clinical Centers are the sites where patients are identified, enrolled, followed, and treated under the study protocols, while the SDRC supports the scientific coordination, data management, and overall research operations needed to run rigorous multi-site studies. The goal of the work is practical and comparative: to design and evaluate outpatient interventions that reduce morbidity in AKI survivors compared with usual care. In other words, the program is not only interested in describing risks after AKI; it is aimed at testing specific post-discharge care strategies that can measurably improve patient outcomes.

This funding opportunity is explicitly a clinical trial required announcement, meaning applicants are expected to propose and conduct clinical trials as part of the work supported under the U01 mechanism. Because it is a cooperative agreement rather than a standard research grant, NIH typically anticipates substantial scientific and programmatic involvement from the funding institute during the project period, with the awardees working in close coordination as a network rather than as fully independent single-site projects.

Eligibility is broad across U.S.-based organizations that can credibly carry out clinical research and deliver outpatient care interventions. Eligible applicants include various levels of government (state, county, city/township, special districts), public and state-controlled institutions of higher education, private institutions of higher education, independent school districts, federally recognized Native American tribal governments, tribal organizations that are not federally recognized, public housing authorities/Indian housing authorities, nonprofit organizations (both 501(c)(3) and non-501(c)(3), excluding institutions of higher education where relevant), for-profit organizations (other than small businesses), and small businesses. The announcement also highlights additional eligible applicant types such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISI), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, regional organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, it clearly restricts non-U.S. participation: non-domestic (non-U.S.) entities are not eligible to apply, non-domestic components of U.S. organizations are not eligible, and foreign components (as defined by the NIH Grants Policy Statement) are not allowed.

Administratively, the opportunity is listed under CFDA 93.847 and falls under the broader activity category of Food and Nutrition, Health. The posting indicates an original closing date of 2020-11-04 and a creation date of 2020-07-07. In practical terms, the opportunity is aimed at building a coordinated, multi-center research effort that can test outpatient care models and interventions for AKI survivors, with the overarching intent of reducing long-term kidney disease progression and the broader cardiovascular and mortality burdens that often follow an AKI hospitalization.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Clinical Centers (U01 Clinical Trial Required)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.847.
• This funding opportunity was created on 2020-07-07.
• Applicants must submit their applications by 2020-11-04. (Agency may still review applications by suitable applicants for the remaining/unused allocated funding in 2026.)
• Eligible applicants include: State governments, County governments, City or township governments, Special district governments, Independent school districts, Public and State controlled institutions of higher education, Native American tribal governments (Federally recognized), Public housing authorities/Indian housing authorities, Native American tribal organizations (other than Federally recognized tribal governments), Nonprofits having a 501 (c) (3) status with the IRS, other than institutions of higher education, Nonprofits that do not have a 501 (c) (3) status with the IRS, other than institutions of higher education, Private institutions of higher education, For-profit organizations other than small businesses, Small businesses, Others.

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