HALT Progression of Polycystic Kidney Disease Study A
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 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; NCT01885559). Participants will be recruited and enrolled, either to Study A or
B, over the first three years. Participants enrolled in Study A will be followed for at least
5 years, while those 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. The two concurrent randomized
clinical trials differ by eligibility criteria, interventions and outcomes to be studied.
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