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.Apply for RFA DK 25 022
- 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.
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Frequently Asked Questions (FAQs)
What is the funding opportunity called and what is the solicitation number?
The opportunity is titled Precision Medicine for Type 1 Diabetic Nephropathy and the solicitation number is RFA-DK-25-022.
What type of NIH award is this?
This is an NIH cooperative agreement using the U01 activity code. Cooperative agreements typically involve substantial NIH and program leadership involvement compared with standard research grants, especially around coordination, procedures, and shared deliverables.
Is this a clinical trial?
No. The opportunity is labeled "Clinical Trial Not Allowed". The emphasis is on cohort enrollment, biospecimen collection (including protocol-driven kidney biopsies), and deep molecular/cellular characterization linked to clinical data over time, rather than testing an intervention.
What program is this expanding or supporting?
This opportunity is designed to expand the Kidney Precision Medicine Project (KPMP) into Type 1 diabetes (T1D) kidney disease, specifically focusing on Type 1 diabetic nephropathy and high-risk individuals.
What is the main scientific goal of the project?
The main goal is to use kidney biopsy tissue from participants with Type 1 diabetes to strengthen and extend KPMP's precision-medicine approach. The work is intended to build or expand a Kidney Tissue Atlas specific to T1D-related nephropathy by integrating biopsy material with KPMP's established modern "omics" and spatial biology methods.
What is the Kidney Tissue Atlas intended to accomplish?
The atlas is intended to map the kidney at cellular and molecular resolution and help break down what is currently grouped under "diabetic nephropathy" into more meaningful disease subtypes. The expectation is that atlas data will clarify which cells and interstitial components are driving damage, which pathways are active in different patient subgroups, and which biological targets may be prioritized for future therapeutic development.
What kinds of organizations or sites is NIH looking to fund?
The program is looking to fund new Recruitment Sites (RS) that can identify, recruit, consent, and longitudinally follow adults and/or children with Type 1 diabetes who either have diabetic nephropathy or are at high risk of developing it, and that can perform protocol-driven research kidney biopsies aligned with KPMP requirements.
What are the key responsibilities of a funded Recruitment Site?
A funded Recruitment Site serves as the "front door" for participants by:
- Finding eligible Type 1 diabetes patients in clinical settings
- Supporting appropriate representation of adult and/or pediatric populations
- Conducting informed consent
- Collecting standardized clinical data and phenotyping information
- Safely obtaining kidney biopsies according to KPMP protocols
- Coordinating closely with KPMP so tissue is processed and analyzed using standardized methods
- Sharing samples and data with KPMP's centralized infrastructure for analysis, quality control, and atlas construction
Why are kidney biopsies central to this opportunity?
A defining feature is the ability to perform protocol-driven research kidney biopsies and coordinate with KPMP so collected tissue can be processed and analyzed using standardized methods. The biopsy tissue is the foundation for the deep molecular and cellular analyses used to build the T1D kidney tissue atlas.
Does the Recruitment Site need to follow participants over time?
Yes. Recruitment Sites are expected to longitudinally follow enrolled participants and link ongoing clinical data with biospecimens and KPMP's downstream analyses.
How closely will awardees need to coordinate with NIH and KPMP?
Because this is a U01 cooperative agreement, awardees should expect close coordination with NIH and KPMP leadership around items such as enrollment targets, adherence to common operating procedures, harmonized clinical phenotyping, uniform biopsy handling, and routine sharing of samples and data into KPMP's centralized infrastructure.
Are current KPMP Recruitment Sites eligible to apply?
No. A specific restriction is that institutions that are already current KPMP Recruitment Sites are not eligible to apply. The intent is to add new centers rather than re-fund or duplicate existing KPMP sites.
Which types of U.S. applicants are eligible to apply?
The opportunity is open to a wide range of U.S.-based applicant organizations, 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 (501(c)(3) and non-501(c)(3))
- For-profit organizations (other than small businesses)
- Small businesses
Are non-U.S. (non-domestic) entities eligible to apply?
No. Non-domestic (non-U.S.) entities are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible.
Are any international collaborations allowed at all?
The information provided indicates that foreign components (as NIH defines them) may be allowed. This typically refers to discrete international collaborations that are justified and compliant with NIH policy, even though the primary applicant must be eligible and U.S.-based.
Does the announcement emphasize any particular institution types?
Yes. The announcement highlights interest in a range of mission-driven or capacity-building institution types, including HBCUs, Hispanic-serving institutions, Tribally Controlled Colleges and Universities (TCCUs), Alaska Native and Native Hawaiian Serving Institutions, and AANAPISIs, as well as faith-based or community-based organizations and certain regional organizations.
What is the Assistance Listing (CFDA) number for this opportunity?
The opportunity is listed under NIH Assistance Listing (CFDA) number 93.847.
What is the application due date?
The original application due date provided is 2024-12-10.
When was the opportunity created?
The opportunity was created on 2024-09-26.
What is the maximum award amount?
The award ceiling listed is $400,000, signaling budgets are expected to support building and operating a recruitment-and-biopsy capable site rather than a large interventional trial.
How many awards will NIH make?
The number of expected awards is not specified in the provided information. This often implies awards may depend on scientific and programmatic priorities, availability of funds, and the number of meritorious applications.
What is the overall deliverable or outcome NIH is aiming for?
The overarching deliverable is not a new treatment trial. Instead, the aim is a sharper biological understanding of Type 1 diabetes kidney disease through an atlas-driven precision-medicine framework that can reveal disease subgroups and point to actionable mechanisms for future therapy development.
In simple terms, what is NIH asking applicants to do?
NIH is asking qualified clinical-research centers to join KPMP as new Type 1 diabetes nephropathy recruitment-and-biopsy hubs that contribute participants, longitudinal clinical data, and high-quality kidney biopsy tissue into a shared national precision-medicine effort.
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