Pilot Clinical Trials in Pediatric Chronic Kidney Disease Participating Clinical Centers (U01)

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The purpose of this Funding Opportunity Announcement (FOA) is to initiate and implement a network of participating clinical centers to perform pilot and feasibility studies of therapies to slow or reverse the progression of chronic kidney disease (CKD) in children. This FOA invites applications for the Participating Clinical Centers (PCCs) and runs in parallel with a separate FOA that invites applications for the Data Coordinating Center (DCC) (RFA-DK-16-035). These pilot studies will seek to optimize critical elements of a full-scale randomized control trial design - the most promising study question, agent(s), target population, dosing, data collection, and appropriate outcomes. Applicants must propose two trials to be conducted sequentially over the funding period. One trial will be to lower serum uric acid levels, while the other can be an appropriately justified study question of the applicant's choosing. When applicable, clinical site investigators may enlist industry collaboration to achieve the goals of the network. The ultimate goal of this FOA is to obtain the necessary information to design and implement one or more full-scale randomized controlled clinical trials of therapies to reduce morbidity in children with CKD.

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