Pilot Clinical Trials in Pediatric Chronic Kidney Disease Participating Clinical Centers (U01) | RFA DK 16 018

Opportunity Information: Apply for RFA DK 16 018

This NIH funding opportunity (RFA-DK-16-018) supports the creation of a network of Participating Clinical Centers (PCCs) to run pilot and feasibility clinical trials focused on pediatric chronic kidney disease (CKD). The overall intent is practical and translational: generate the key design and operational information needed to move toward one or more full-scale, randomized controlled trials (RCTs) that can meaningfully slow, halt, or potentially reverse CKD progression in children and ultimately reduce illness and complications tied to pediatric CKD. The award mechanism is a U01 cooperative agreement, meaning NIH expects substantial programmatic involvement and coordination rather than a fully investigator-driven, hands-off grant.

A central feature of the program is that each applicant clinical center must propose two pilot trials that will be conducted sequentially during the funding period. One of those trials is required to focus on lowering serum uric acid, reflecting NIH interest in testing whether uric acid reduction can influence CKD progression or related outcomes in children. The second trial is chosen by the applicant, but it must be clearly justified as an important and feasible therapeutic question for pediatric CKD. Across both pilots, the studies are expected to do more than simply test a hypothesis; they are meant to refine the building blocks of a future definitive RCT. That includes identifying the most promising intervention(s), defining the right target population, selecting dosing and treatment strategies, establishing workable recruitment and retention approaches, standardizing data collection procedures, and choosing outcomes and endpoints that are clinically meaningful and realistically measurable in children.

This PCC FOA is designed to run in parallel with a companion announcement for a Data Coordinating Center (DCC) (RFA-DK-16-035). In practice, that means the clinical centers funded under this opportunity are expected to work closely with the DCC to ensure consistent protocols, data standards, quality assurance, safety reporting, and overall trial operations across the network. The network approach is meant to speed learning, improve consistency, and make it easier to scale from pilot work to a larger multi-site RCT once the most effective design choices are identified.

The announcement also allows, when appropriate, collaboration with industry partners to help the network meet its goals. This is framed as a practical tool rather than a requirement, and would typically be relevant when access to study agents, matching placebo, manufacturing support, or specialized expertise is needed to conduct the trials properly and in compliance with regulatory and quality expectations.

Eligibility is broad and includes many types of domestic organizations: state, county, and local governments; public and private institutions of higher education; federally recognized tribal governments and other tribal organizations; independent school districts; special district governments; public housing authorities; nonprofits with or without 501(c)(3) status; for-profit organizations (other than small businesses) and small businesses; and other eligible entities. The FOA also explicitly notes inclusion of organizations such as Alaska Native and Native Hawaiian Serving Institutions, AANAPISI institutions, Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), faith-based or community-based organizations, eligible federal agencies, and U.S. territories or possessions. At the same time, non-U.S. organizations and non-U.S. institutional components are not eligible to apply as applicants. However, foreign components may be permitted under NIH policy as part of a U.S.-based application, as defined in the NIH Grants Policy Statement.

Administratively, the opportunity is categorized as discretionary funding and uses the cooperative agreement instrument (U01) under a health-related activity category (listed as Food and Nutrition, Health) with CFDA number 93.847. The posting lists an award ceiling of $250,000 and an original application due date of February 17, 2017, with the FOA created on October 27, 2016. The overarching deliverable expected from funded PCCs is a set of well-executed pilot trials that clarify feasibility and optimize trial design choices so the field can confidently launch larger RCTs aimed at reducing morbidity and improving outcomes for children living with CKD.

• 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 Participating Clinical Centers (U01)" 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 $250,000.00 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 16 018

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