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

Frequently Asked Questions (FAQs)

1) What is RFA-DK-16-025?

RFA-DK-16-025 is a National Institutes of Health (NIH) funding opportunity to establish and operate the APOL1 Long-term Kidney Transplantation Outcomes Research Network (APOLLO) through cooperative agreements (U01). It supports a multi-center, multi-disciplinary set of Clinical Centers that will work together as a coordinated research network focused on kidney transplantation outcomes.

2) What is the APOLLO Network?

APOLLO is a coordinated research network designed to study how APOL1 genetic variants relate to long-term kidney transplantation outcomes in the United States. The program is organized as a consortium, with participating sites sharing responsibilities, following common protocols, and operating under coordinated oversight.

3) What types of awards does this opportunity use?

This opportunity uses the NIH cooperative agreement mechanism (U01).

4) What does it mean that this is a cooperative agreement (U01) rather than a standard grant?

Because this is a cooperative agreement, NIH is expected to have substantial scientific or programmatic involvement. Funded sites are expected to function as a consortium with shared responsibilities, common protocols, and coordinated oversight rather than operating as fully independent projects.

5) What is being funded under RFA-DK-16-025 specifically?

RFA-DK-16-025 specifically targets the establishment and operation of APOLLO Network Clinical Centers (CCs). These Clinical Centers are responsible for identifying participants, enrolling and following them over time, and collecting clinical data and biospecimens under standardized procedures.

6) Is there a separate funding opportunity for coordination and data management?

Yes. This funding opportunity runs in parallel with a separate NIH announcement for the APOLLO Network Scientific Data Research Center (SDRC), listed as RFA-DK-16-024. The SDRC is intended to provide centralized data management and research support functions for the overall program.

7) How do the Clinical Centers (CCs) and the SDRC differ?

The Clinical Centers focus on on-the-ground clinical operations: identifying participants, enrolling them, conducting follow-up, and collecting clinical data and biospecimens using standardized procedures. The SDRC is intended to provide centralized data management and research support. The structure separates clinical operations from network-wide coordination while still requiring tight integration between the two.

8) What is the main scientific focus of the APOLLO research network?

The main focus is the role of APOL1 genetic variants in kidney transplantation, specifically clarifying how these variants affect long-term transplant outcomes in the United States.

9) Why are APOL1 variants important in this program?

APOL1 risk variants have been associated with a higher risk of certain kidney diseases in individuals with recent African ancestry. APOLLO is designed to clarify how these variants, particularly donor APOL1 genotype, relate to transplant outcomes over the long term.

10) What study design is described for APOLLO?

The network is built around a prospective, longitudinal cohort. This means participants are followed forward in time with repeated assessments, allowing the program to measure changes in kidney function and other outcomes as they occur, rather than relying only on retrospective records.

11) Who is the primary recipient population of interest?

The primary recipient population of interest is U.S. kidney transplant recipients who received kidneys from African American donors, because donor APOL1 genotype is a key susceptibility factor being evaluated.

12) Does the network also follow kidney donors?

Yes. In addition to tracking transplant recipients, the consortium will follow African American kidney donors to understand donor outcomes over time.

13) What donor outcomes are intended to be assessed?

Donor follow-up is meant to assess outcomes such as vital status and renal functional status to the greatest extent possible, while acknowledging the practical challenges of long-term follow-up in donor populations.

14) Why include donor follow-up as part of the network?

The dual focus is intended to address not only graft survival and recipient health, but also the longer-term health trajectory of African American kidney donors. This information may help inform clinical counseling, donor selection, and post-donation monitoring strategies.

15) What are the primary outcomes for transplant recipients identified in the FOA?

The FOA identifies several primary outcomes for transplant recipients: the rate of change of kidney function over time, rates of acute rejection episodes, graft failure, and return to maintenance dialysis.

16) What kinds of endpoints do these outcomes represent?

These outcomes include intermediate clinical events (such as acute rejection) and longer-term outcomes that strongly affect patient health and healthcare utilization (such as graft failure and return to maintenance dialysis).

17) What is the intended value of using shared endpoints and standardized procedures across sites?

By anchoring the network around shared endpoints and a standardized cohort design, APOLLO is positioned to generate results that are comparable across sites and strong enough to inform future clinical practice and policy discussions related to genetic testing and organ allocation.

18) Who is eligible to apply?

Eligibility is broad and includes many NIH applicant categories such as 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); small businesses; tribal governments; and tribal organizations.

19) Are minority-serving institutions and community-based organizations eligible?

Yes. The announcement explicitly highlights eligibility for 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). It also notes faith-based or community-based organizations, and U.S. territories or possessions.

20) Are foreign organizations or foreign components allowed?

No. Non-domestic (non-U.S.) entities and non-domestic components of U.S. organizations are not eligible to apply. Foreign components (as defined by NIH policy) are not allowed, meaning the work and infrastructure need to be fully U.S.-based.

21) Which agency is offering this opportunity?

The opportunity is offered through the National Institutes of Health (NIH).

22) How is the funding opportunity categorized?

The opportunity is categorized as discretionary funding and uses the cooperative agreement mechanism. It is listed in a health-related activity category (also tagged in the source data as Food and Nutrition, Health).

23) What CFDA numbers are associated with this opportunity?

The FOA lists CFDA numbers 93.307, 93.847, 93.855, 93.856.

24) What is the application closing date listed in the provided information?

The original closing date provided is February 24, 2017.

25) When was the FOA created?

The FOA was created on November 16, 2016.

26) What is the award ceiling shown in the provided record?

The source data lists an award ceiling of $200,000.

27) How many awards are expected?

The number of expected awards is not specified in the provided record.

28) What is the overall purpose of building the APOLLO Clinical Center network?

The overall purpose is to build a national clinical research network capable of producing 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.

29) What does it mean for funded sites to operate as a consortium?

Operating as a consortium means the funded Clinical Centers are expected to work together under shared responsibilities, common protocols, and coordinated oversight, rather than pursuing unrelated or site-specific approaches.

30) What kinds of activities are Clinical Centers expected to perform?

Clinical Centers are expected to identify participants, enroll them, follow them over time, and collect clinical data and biospecimens using standardized procedures. They also participate in network-wide coordination consistent with the consortium model described in the FOA.