Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (U01 Clinical Trial Required) | RFA DK 20 012

Opportunity Information: Apply for RFA DK 20 012

The Caring for OutPatiEnts after Acute Kidney Injury (COPE-AKI) Scientific and Data Research Center (SDRC) funding opportunity (RFA-DK-20-012) is a National Institutes of Health (NIH) cooperative agreement (U01) focused on improving outcomes for people who survive moderate to severe acute kidney injury (specifically Stage 2 and Stage 3 AKI). The public health problem it targets is clear: AKI is common and is strongly linked to serious long-term consequences, including progression to chronic kidney disease (CKD), end-stage kidney disease (ESKD), higher cardiovascular risk, and increased mortality. The opportunity highlights that the risk is not uniform; it rises with more severe, longer-lasting, or repeated AKI episodes and is amplified by factors such as older age, pre-existing CKD, and other comorbid conditions. Despite these known risks, the field still lacks strong evidence about which outpatient care processes or therapeutic strategies actually prevent kidney decline and downstream complications after patients leave the hospital, making AKI survivorship a major missed prevention window.

The COPE-AKI program is designed as a consortium model made up of approximately 3 to 4 Clinical Centers (CCs) plus a centralized Scientific and Data Research Center (SDRC). Together, the consortium is expected to develop and rigorously test interventions intended to reduce morbidity in AKI survivors compared to usual care. Because this is a U01 cooperative agreement, NIH expects substantial scientific involvement during the project, meaning the awardee and NIH staff work collaboratively on study oversight, milestone-driven progress, and coordination across sites. The “Clinical Trial Required” designation signals that the research will include a prospective interventional study (not just observational work), and the SDRC plays a central role in ensuring the trial is designed, executed, monitored, and analyzed in a consistent and high-quality way across all participating clinical sites.

The SDRC’s purpose within the consortium is to function as the operational and scientific backbone for the multi-site effort. In practice, this typically includes responsibilities such as coordinating protocol development and harmonization across clinical centers; leading statistical design and power calculations; developing the data management platform and common data elements; overseeing data quality control, validation, and secure handling of source data; and ensuring consistent implementation of study procedures. The SDRC is also commonly responsible for randomization support (if applicable), interim monitoring and reporting, safety oversight coordination, and producing analyses and reporting outputs that can drive actionable conclusions about what improves post-AKI outcomes. In a program like this, the SDRC often supports collaboration structures as well, such as steering committee operations, shared documentation, training resources, and cross-site communication workflows so that recruitment, follow-up, and intervention delivery are comparable across centers.

In terms of who can apply, eligibility is broad and includes many domestic organization types: state, county, and local governments; special district governments; independent school districts; public and private institutions of higher education; federally recognized Native American tribal governments; tribal organizations (including those other than federally recognized governments); public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status (as long as they are not institutions of higher education for those categories); for-profit organizations (other than small businesses); small businesses; and other entities. The opportunity also explicitly calls out additional eligible applicants such as Alaska Native and Native Hawaiian Serving Institutions, Asian American Native American Pacific Islander Serving Institutions (AANAPISISs), Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, regional organizations, and U.S. territories or possessions. At the same time, it draws firm boundaries around foreign involvement: non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply, and foreign components (as defined by NIH policy) are not allowed under this announcement.

Administratively, the opportunity is listed as discretionary funding using the cooperative agreement instrument, and it falls under the health-related activity category (with CFDA listing 93.847). The original application due date was November 4, 2020, and the posted award ceiling was $500,000. Overall, the grant’s core aim is to build evidence-based outpatient strategies after serious AKI by using a coordinated multi-site clinical trial structure, with the SDRC ensuring the scientific rigor, data integrity, and cross-center consistency needed to produce results that can change post-AKI care and reduce preventable kidney disease progression, cardiovascular complications, and premature death.

• 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) Scientific and Data Research Center (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.)
• Each selected applicant is eligible to receive up to $500,000.00 in funding.
• 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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