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

Frequently Asked Questions (FAQs): NIH RFA-DK-16-035 (U24) Pilot Clinical Trials in Pediatric CKD Data Coordinating Center

What is RFA-DK-16-035?

RFA-DK-16-035 is a National Institutes of Health (NIH) funding opportunity titled "Pilot Clinical Trials in Pediatric Chronic Kidney Disease Data Coordinating Center (U24)." It supports the creation and operation of a Data Coordinating Center (DCC) for a coordinated, multi-site clinical trials network focused on children with chronic kidney disease (CKD).

What is the main purpose of this funding opportunity?

The purpose is to stand up the central infrastructure needed to run coordinated pilot and feasibility clinical trials in pediatric CKD. The network is intended to test interventions aimed at slowing, stopping, or potentially reversing CKD progression in children and to generate the operational and scientific evidence needed to plan later, definitive randomized controlled trials.

What type of award mechanism is used?

This opportunity uses the U24 cooperative agreement mechanism. Under a cooperative agreement, NIH staff typically have substantial involvement in the project, participating as a partner in planning, oversight, and coordination rather than acting only as a passive funder.

Is this opportunity for clinical sites or for a coordinating center?

This specific announcement is for the Data Coordinating Center (DCC). It is intended to run alongside a companion announcement for Participating Clinical Centers (PCCs) under RFA-DK-16-018.

What does the Data Coordinating Center (DCC) do in this network?

Based on the description provided, the DCC acts as the central hub enabling a multi-site trial network to function. Core responsibilities include supporting study start-up and harmonization across sites, managing data systems and quality control, coordinating protocol implementation, and supporting consistent operations and reporting across the network.

What kind of studies does the program emphasize?

The program is explicitly structured around pilot and feasibility studies rather than an immediate, large-scale definitive phase III-style trial. The pilot work is intended to pressure-test key design decisions that determine whether a later randomized controlled trial is likely to be feasible and successful.

What is the long-term goal of the initiative?

The long-term goal is to produce trial-ready evidence and infrastructure that supports one or more full-scale randomized controlled clinical trials designed to reduce morbidity in children with CKD. Expected outputs include clearer eligibility and recruitment assumptions, improved endpoint selection, better approaches to adherence and safety monitoring, more reliable data workflows, and preliminary signals that can justify definitive trials.

Are applicants required to propose specific clinical trials?

Yes. A central requirement is that applicants propose two clinical trial designs that will be carried out sequentially over the project period.

Is there a required scientific focus for one of the trials?

Yes. One of the two sequential trials must focus on lowering serum uric acid levels, reflecting a specific scientific priority in the funding opportunity.

What about the second trial design?

The second trial can focus on another therapeutic strategy, but it must be well-justified and scientifically appropriate for pediatric CKD.

Why does NIH require two sequential trial designs?

Requiring two planned studies signals that NIH expects both (1) a programmatic priority study (uric-acid lowering) and (2) an additional, investigator-driven question that could broaden the network's usefulness and help identify promising interventions to move forward.

What kinds of trial design issues are the pilot studies intended to address?

The pilot and feasibility work is intended to refine "critical elements" of trial design, 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 clinically meaningful and realistically measurable in children.

What challenges in pediatric CKD research does this program recognize?

The opportunity highlights pediatric-specific challenges such as smaller patient pools, developmental variability, dosing and pharmacokinetic uncertainty, and the need for outcomes that capture meaningful kidney and broader health trajectories over time.

Who is eligible to apply?

Eligibility is broad and includes many types of U.S.-based organizations and governmental entities. Examples listed include 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.

Are specific institution types explicitly called out as eligible?

Yes. The eligibility description also calls out categories such as 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.

Can foreign institutions apply?

No. Foreign institutions are not eligible to apply.

Can a U.S. organization apply if it has non-U.S. components involved?

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 certain project elements may involve foreign collaborations or activities if they meet NIH definitions and are justified and approved under NIH policy.

What is the CFDA number associated with this opportunity?

The opportunity is listed under CFDA 93.847.

When was this opportunity posted and when was it originally due?

It was originally posted on 2016-10-27, with an original closing date of 2017-02-17.

What is the award ceiling listed for this opportunity?

The listed award ceiling is $350,000.

How does this DCC opportunity relate to the Participating Clinical Centers (PCCs)?

This DCC FOA is designed to run alongside a companion FOA for Participating Clinical Centers (PCCs) under RFA-DK-16-018. In practical terms, the DCC enables coordinated, consistent multi-site trial execution across the participating clinical centers.

What is the expected role of the DCC in ensuring trial quality?

The DCC is described as managing data systems and quality control, coordinating protocol implementation, and supporting consistent operations and reporting. These functions are intended to ensure that multi-site pediatric CKD trials are run consistently and that the resulting data can credibly inform next-step definitive trials.

Is this funding opportunity primarily about building infrastructure or generating clinical results?

It is focused on both, with a clear emphasis on building coordinated network infrastructure that can run pilot and feasibility trials. The expected product is operational and scientific evidence that strengthens the blueprint for later definitive randomized controlled trials.