The summary for the Frequent Hemodialysis Clinical Trials Federal Grant is detailed below.
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The Division of Kidney, Urologic and Hematologic Diseases (DKUHD) of the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) invites cooperative agreement applications for a Data and Analysis Coordinating Center (DACC) and two Coordinating Clinical Centers (CCCs) to design, develop and implement clinical treatment trials of frequent hemodialysis for patients with end stage renal disease (ESRD). The DACC and CCCs will propose trial designs for the studies. It is anticipated that two trials will be initiated, one comparing short daily hemodialysis with conventional dialysis and one comparing long nocturnal dialysis with conventional dialysis. The goal of the RFA is to test the feasibility of randomizing a representative sample of dialysis patients into either (a) conventional three times per week dialysis, or (b) one of the two forms of frequent dialysis named above and to obtain preliminary data on the impact of these modalities on patient well-being. It is expected that patients will be followed for a minimum of six months and that intermediate outcomes will be tracked such as anemia, nutritional status, blood pressure, left ventricular hypertrophy, exercise tolerance, medication use, hospitalizations, etc. Based on the results of these trials, NIDDK will determine the advisability of continuing with a large scale trial of daily dialysis, powered to measure the impact of more frequent dialysis on hard endpoints, such as mortality and/or cardiovascular outcomes. The structure of the trials will be determined in part by the proposals. However, it is expected that the DACC will be responsible for coordinating the project design, monitoring data collection, and statistical analyses. Each CCC will be responsible for enrolling patients into the trials, monitoring the dialysis interventions, and data collection. It is not necessary that a CCC be able to enroll the entire patient cohort at a single site. A CCC may work out cooperative arrangements with a network of dialysis providers to reach enrollment goals. It is expected that CCCs will be given a fixed payment for the infrastructure for the trial and variable payments based on attaining enrollment goals.