Pilot Clinical Trials in Pediatric Chronic Kidney Disease Data Coordinating Center (U24) | RFA DK 16 035

Opportunity Information: Apply for RFA DK 16 035

The National Institutes of Health (NIH) funding opportunity RFA-DK-16-035, titled "Pilot Clinical Trials in Pediatric Chronic Kidney Disease Data Coordinating Center (U24)," supports the creation and operation of a Data Coordinating Center (DCC) for a coordinated clinical trials network focused on children with chronic kidney disease (CKD). The overall intent is to stand up a multi-site infrastructure that can run pilot and feasibility trials aimed at slowing, stopping, or potentially reversing CKD progression in pediatric populations. This award uses a U24 cooperative agreement mechanism, which typically means NIH staff will have substantial involvement in the project as a partner in planning, oversight, and coordination rather than acting only as a passive funder.

This announcement is specifically for the DCC and is designed to run alongside a companion announcement for Participating Clinical Centers (PCCs) under RFA-DK-16-018. In practical terms, the DCC serves as the central hub that makes a network trial possible: it supports study start-up and harmonization across sites, manages data systems and quality control, coordinates protocol implementation, and helps ensure consistent operations and reporting. The program is explicitly structured around pilot and feasibility studies, not immediately around a definitive, large-scale phase III-style trial. The pilot work is meant to pressure-test the key design decisions that make or break a later randomized controlled trial, including selecting the best study question and intervention(s), defining the target pediatric subpopulation, refining dosing strategies, standardizing data collection, and choosing outcomes that are both clinically meaningful and realistically measurable in children.

A central requirement is that applicants propose two clinical trial designs that will be carried out sequentially over the project period. One of these trials must focus on lowering serum uric acid levels, reflecting a specific scientific priority embedded in the FOA. The second trial can address another therapeutic strategy, but it must be well-justified and scientifically appropriate for pediatric CKD. By forcing two planned studies, the NIH is signaling that it wants both a required, programmatic priority (uric-acid lowering) and an additional, investigator-driven question that could broaden the network's usefulness and help identify the most promising intervention(s) to take forward.

The long-term goal of this initiative is not just to run small studies, but to generate the operational and scientific evidence needed to design one or more full-scale randomized controlled clinical trials that can reduce morbidity in children with CKD. In other words, the expected product is a stronger, trial-ready blueprint: clearer eligibility and recruitment assumptions, better endpoint selection, better adherence and safety monitoring approaches, more reliable data workflows, and enough preliminary efficacy or biomarker signal to justify a definitive trial. The emphasis on optimizing "critical elements" of trial design highlights that pediatric CKD research faces challenges like smaller patient pools, developmental variability, dosing and pharmacokinetic uncertainty, and the need for outcomes that capture meaningful kidney and broader health trajectories over time.

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities, such as state, county, and local governments; public and private institutions of higher education; independent school districts; special district governments; federally recognized tribal governments and certain tribal organizations; public housing authorities/Indian housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses); and small businesses, among others. The FOA also calls out additional eligible applicant categories including Alaska Native and Native Hawaiian Serving Institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), Asian American Native American Pacific Islander Serving Institutions (AANAPISI), faith-based or community-based organizations, certain tribal governments that are not federally recognized, regional organizations, and U.S. territories or possessions.

Foreign institutions are not eligible to apply, and non-U.S. components of U.S. organizations are not eligible to apply. However, "foreign components" as defined by the NIH Grants Policy Statement are allowed, meaning that while the applicant organization must be eligible and U.S.-based, certain project elements may involve foreign collaborations or activities if they meet NIH definitions and are justified and approved under NIH policy.

Administratively, this is a discretionary grant opportunity under the health-related NIH umbrella (CFDA 93.847) and was originally posted on 2016-10-27 with an original closing date of 2017-02-17. The award ceiling listed is $350,000. The opportunity is framed around building a coordinated network and delivering two sequential pilot trial designs, with the DCC positioned as the backbone entity that enables multi-site pediatric CKD trials to run consistently, safely, and with data that can credibly inform the next step: a larger, definitive randomized trial program intended to improve outcomes for children living with chronic kidney disease.

• The National Institutes of Health in the food and nutrition, health sector is offering a public funding opportunity titled "Pilot Clinical Trials in Pediatric Chronic Kidney Disease Data Coordinating Center (U24)" 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 2016-10-27.
• Applicants must submit their applications by 2017-02-17. (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 $350,000.00 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 16 035

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