APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Centers (Collaborative U01) | RFA DK 16 025

Opportunity Information: Apply for RFA DK 16 025

The National Institutes of Health (NIH) funding opportunity RFA-DK-16-025 supports the creation of the APOL1 Long-term Kidney Transplantation Outcomes Research Network (APOLLO) through cooperative agreements (U01). The goal is to stand up a multi-center, multi-disciplinary set of Clinical Centers that will work together as a coordinated research network focused on kidney transplantation outcomes. Because this is a cooperative agreement rather than a standard grant, NIH is expected to have substantial scientific or programmatic involvement in the work, and the funded sites will operate as a consortium with shared responsibilities, common protocols, and coordinated oversight.

This FOA specifically targets the establishment and operation of APOLLO Network Clinical Centers (CCs). It runs in parallel with a separate NIH announcement for a complementary coordinating entity, the APOLLO Network Scientific Data Research Center (SDRC) (RFA-DK-16-024). In practical terms, the Clinical Centers are the places where participants are identified, enrolled, and followed, and where clinical data and biospecimens are collected under standardized procedures. The SDRC is intended to provide centralized data management and research support functions, so the overall program is structured to separate on-the-ground clinical operations from the network-wide data and scientific coordination infrastructure while still requiring tight integration between the two.

The research focus of APOLLO is the role of APOL1 genetic variants in kidney transplantation. APOL1 risk variants have been associated with higher risk of certain kidney diseases in individuals with recent African ancestry, and this network is designed to clarify how these variants affect long-term transplant outcomes in the United States. The studies will be built around a prospective, longitudinal cohort, meaning participants are followed forward in time with repeated assessments, allowing investigators to measure changes in kidney function and other outcomes as they occur rather than relying only on retrospective records. The primary recipient population of interest is U.S. kidney transplant recipients who received kidneys from African American donors, since donor APOL1 genotype is a key susceptibility factor being evaluated.

In addition to tracking recipients, the consortium will follow African American kidney donors to understand donor outcomes over time. Donor follow-up is meant to assess outcomes such as vital status and renal functional status to the greatest extent possible, acknowledging the practical challenges of long-term follow-up in donor populations. This dual focus reflects an interest not only in graft survival and recipient health, but also in the longer-term health trajectory of living (and potentially deceased donor-related data where feasible) African American donors, helping to inform clinical counseling, donor selection, and post-donation monitoring strategies.

The FOA identifies several primary outcomes for transplant recipients. These include the rate of change of kidney function over time, rates of acute rejection episodes, graft failure, and return to maintenance dialysis. Together, these endpoints capture both intermediate clinical events (like acute rejection) and the longer-term hard outcomes (graft failure and dialysis) that matter most for patient health, healthcare utilization, and transplant program performance. By anchoring the network around these shared endpoints and a standardized cohort design, APOLLO is positioned to produce results that are comparable across sites and strong enough to guide future clinical practice and policy discussions related to genetic testing and organ allocation.

Eligibility is broad and spans many typical NIH applicant categories, including state, county, and local governments; public and private institutions of higher education; nonprofit organizations with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, along with tribal governments and tribal organizations. The announcement also explicitly highlights additional eligible applicant 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 (AANAPISISs), as well as faith-based or community-based organizations and U.S. territories or possessions. At the same time, the FOA clearly restricts 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, which means the work and infrastructure need to be fully U.S.-based.

From an administrative standpoint, the opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism. It is listed under NIH with CFDA numbers 93.307, 93.847, 93.855, 93.856, and it sits in the health-related activity category (also tagged in the source data as Food and Nutrition, Health). The original closing date provided is February 24, 2017, and the source data lists an award ceiling of $200,000, with the number of expected awards not specified in the provided record. The FOA was created on November 16, 2016. Overall, the opportunity is best understood as an NIH-led effort to build a national clinical research network capable of generating definitive, longitudinal evidence about how APOL1 genetic risk in donors relates to transplant outcomes, while also documenting longer-term health outcomes for African American kidney donors.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "APOL1 Long-term Kidney Transplantation Outcomes Network (APOLLO) Clinical Centers (Collaborative U01)" and is now available to receive applicants.
• Interested and eligible applicants and submit their applications by referencing the CFDA number(s): 93.307, 93.847, 93.855, 93.856.
• This funding opportunity was created on 2016-11-16.
• Applicants must submit their applications by 2017-02-24. (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 $200,000.00 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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