National Institutes of Health

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 & 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) > 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.

Who can apply

• Others

Contact

NIH OER Webmaster<br/>FBOWebmaster@OD.NIH.GOV<br/>
FBOWebmaster@OD.NIH.GOV