HALT Progression of Polycystic Kidney Disease Study B
Status:
Completed
Trial end date:
2014-06-01
Target enrollment:
Participant gender:
Summary
The efficacy of interruption of the renin-angiotensin-aldosterone system (RAAS) on the
progression of cystic disease and on the decline in renal function in autosomal dominant
kidney disease (ADPKD) will be assessed in two simultaneous multicenter randomized clinical
trials targeting different levels of kidney function: 1) early disease defined by GFR >60
mL/min/1.73 m2 (Study A); and 2) moderately advanced disease defined by GFR 25-60 mL/min/1.73
m2 (Study B). Participants will be recruited and enrolled, either to Study A or B, over the
first three years. Participants enrolled in Study B will be followed for five-to-eight years,
with the average length of follow-up being six and a half years.
Combination therapy will use angiotensin-converting-enzyme inhibitor (ACE-I) and an
angiotensin-receptor blocker (ARB). Monotherapy will use ACE-I alone.
Phase:
Phase 3
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborators:
Boehringer Ingelheim Merck Sharp & Dohme Corp. Polycystic Kidney Disease Foundation University of Pittsburgh Washington University School of Medicine