OpportunityTitle: Limited Competition for the Continuation of the Halt-Polycystic Kidney Disease Trials Data Coordinating Center (DCC) (U01)
AdditionalInformationOnEligibility: Other Eligible Applicants include the following:  As this FOA is a limited competition opportunity, only the institution that is the principal employer of the Program Director(s)/Principal Investigator(s) of the HALT Data Coordinating Center is eligible to apply to this FOA.  Non-domestic (non-U.S.) Entities (Foreign Institutions) are not eligible to apply. Non-domestic (non-U.S.) components of U.S. Organizations are not eligible to apply.  Foreign components, as defined in the NIH Grants Policy Statement, are not allowed.
Description: The purpose of this limited competition is to extend the activities of the Data Coordinating Center (DCC) during the final two years of patient follow-up of the two ongoing HALT-Polycystic Kidney Disease (PKD) clinical trials. The extension will insure the statistical power and significance of the study outcomes. The HALT-PKD Trials are comprised of two studies (A &amp; B) that are both fully enrolled. HALT-PKD Study A is evaluating the impact of renin-angiotensin-aldosterone system (RAAS) blockade on progression of disease in 548 hypertensive PKD patients with estimated glomerular filtration rate (GFR) &gt; 60ml/min/1.73 m2. The primary endpoint of the study is the percent change in total kidney volume, as measured by magnetic resonance imaging (MRI) over time. HALT-PKD Study B is evaluating the impact of RAAS blockade on progression of disease in 472 hypertensive PKD patients with estimated GFR 30-60 ml/min/1.73 m2. The primary endpoint of Study B is a composite endpoint of time to the 50% reduction of baseline estimated GFR, ESRD (initiation of dialysis or preemptive transplant), or death.
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