Precision Medicine for Type 1 Diabetic Nephropathy (U01 Clinical Trial Not Allowed) | RFA DK 25 022

Opportunity Information: Apply for RFA DK 25 022

The Precision Medicine for Type 1 Diabetic Nephropathy funding opportunity (RFA-DK-25-022) is an NIH cooperative agreement (U01) aimed at expanding the Kidney Precision Medicine Project (KPMP) into Type 1 diabetes (T1D) kidney disease. The program is looking to fund new Recruitment Sites (RS) that can identify, recruit, consent, and longitudinally follow adults and/or children with T1D who either have diabetic nephropathy or are considered at high risk of developing it. A defining feature of the work is the ability to perform protocol-driven research kidney biopsies and to coordinate closely with KPMP so that collected tissue can be processed and analyzed using standardized methods. Although this is a U01, it is labeled “Clinical Trial Not Allowed,” meaning applicants are not being asked to run an interventional trial; the emphasis is on cohort enrollment, biospecimen collection, and deep molecular and cellular characterization tied to clinical data over time.

The core scientific purpose is to use kidney biopsy tissue from T1D participants to strengthen and extend KPMP’s precision-medicine approach to diabetic kidney disease. By integrating high-quality biopsy material with modern “omics” and spatial biology techniques already established within KPMP, the project aims to build or expand a Kidney Tissue Atlas specific to T1D-related nephropathy. The atlas is intended to map the kidney at cellular and molecular resolution, helping researchers separate what is currently grouped under “diabetic nephropathy” into more meaningful disease subtypes. Ultimately, the expectation is that these data will clarify which cells and interstitial components are driving damage, which pathways are most active in different patient subgroups, and which biological targets could be prioritized for future therapeutic development.

Functionally, a funded Recruitment Site would serve as the front door for participants: finding eligible patients in clinical settings, ensuring appropriate representation of adult and/or pediatric populations, conducting informed consent and standardized data collection, and safely obtaining kidney biopsies according to KPMP protocols. Because the award mechanism is a cooperative agreement, the NIH and KPMP leadership typically have substantial programmatic involvement compared with a standard research grant. In practical terms, that usually translates into close coordination around enrollment targets, adherence to common operating procedures, harmonized clinical phenotyping, uniform biopsy handling, and routine sharing of samples and data with KPMP’s centralized infrastructure for analysis, quality control, and atlas construction.

This NOFO is specifically restricted in a way that matters for potential applicants: institutions that are already current KPMP Recruitment Sites are not eligible to apply. The intent is to bring in new centers rather than re-fund or duplicate existing KPMP sites. At the same time, the opportunity is broad in who may apply across the U.S. research and healthcare ecosystem, including state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; independent school districts and special district governments; public housing/Indian housing authorities; nonprofits (both 501(c)(3) and non-501(c)(3)); for-profit organizations (other than small businesses); and small businesses. The announcement also highlights interest in a range of mission-driven or capacity-building institution types, such as Historically Black Colleges and Universities (HBCUs), Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and Asian American Native American Pacific Islander Serving Institutions (AANAPISIs), as well as faith-based or community-based organizations and certain regional organizations. Non-domestic (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible; however, foreign components (as NIH defines them) may be allowed, which generally means discrete international collaborations could be permissible if justified and compliant with NIH policy.

From an administrative standpoint, the opportunity falls under the NIH’s health-related assistance listing (CFDA/Assistance Listing number 93.847). The original application due date is listed as 2024-12-10, and the opportunity was created on 2024-09-26. The award ceiling is listed as $400,000, signaling that budgets are expected to be sized around building and operating a recruitment-and-biopsy capable site rather than running a large, multi-center interventional trial. The number of expected awards is not specified in the provided source data, which often indicates NIH may make awards based on scientific and programmatic need, availability of funds, and the number of meritorious applications.

In summary, this NOFO is essentially asking qualified clinical-research centers to join KPMP as new Type 1 diabetes nephropathy recruitment-and-biopsy hubs. The funded sites would contribute participants, longitudinal clinical data, and high-quality kidney biopsy tissue into a shared national precision-medicine effort. The overarching deliverables are not a new treatment trial, but a sharper biological understanding of T1D kidney disease through an atlas-driven framework that can reveal disease subgroups and pinpoint actionable mechanisms for future therapy development.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Precision Medicine for Type 1 Diabetic Nephropathy (U01 Clinical Trial Not Allowed)" 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 2024-09-26.
• Applicants must submit their applications by 2024-12-10. (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 $400,000.00 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.

Apply for RFA DK 25 022

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