This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This is a large randomized clinical trial to determine the impact of intensive blockage of the renin-angiotensinaldosterone system (RAAS) and the level of blood pressure control on progressive renal disease in individuals with early or more advanced stages of autosomal dominant polycystic kidney disease (ADPKD). In Study A, subjects with a glomerular filtration rate (GFR) greater than 60 ml/min/1.73 m2, will be randomized to one of four conditions in a 2-by-2 design: combination angiotensin-converting enzyme inhibitor (ACE-I) and angiotensin receptor blocker (ARB) therapy at two levels of blood pressure control (systolic less than or equal to 130 and diastolic less than or equal to 85mm Hg vs. systolic less than or equal to 110 and diastolic less than or equal to 70 mm Hg) or Beta-Blocker therapy at two levels of blood pressure control (systolic less than or equal to 130 and diastolic less than or equal to 85 mm Hg vs. systolic less than or equal to 110 and diastolic less than or equal to 70 Hg). The primary outcome of Study A is the percent change in total kidney volume by Magnetic Resonance Imaging (MRI). Study B will assess the effects with ACE-I, with both groups treated to standard levels of blood pressure control on the time to a composite of doubling of serum creatinine, end-stage renal disease (ESRD), or death.

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
5M01RR018390-04
Application #
7377718
Study Section
National Center for Research Resources Initial Review Group (RIRG)
Project Start
2006-04-01
Project End
2007-03-31
Budget Start
2006-04-01
Budget End
2007-03-31
Support Year
4
Fiscal Year
2006
Total Cost
$918
Indirect Cost
Name
Cleveland Clinic Lerner
Department
Other Basic Sciences
Type
Schools of Medicine
DUNS #
135781701
City
Cleveland
State
OH
Country
United States
Zip Code
44195
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