NCT00413777 - Tolvaptan Open-label Pilot Efficacy, Tolerability, and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD) | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

December 31, 2005

Primary Completion Date

June 30, 2010

Study Completion Date

June 30, 2010

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

DRUG

Tolvaptan

Participants were titrated to either the tolvaptan 45/15 or 60/30 mg split-dose over a 2-month Titration Period. They received the titrated dose for 34 months during the Fixed-dose Period. Following a planned off-treatment period, participants had the option to enter an Extension Period for an additional 12 months. Tolvaptan was supplied as tablets.

Trial Locations (11)

Unknown

University of Colorado, Denver

Jacksonville Center for Clinical Research, Jacksonville

Emory University School of Medicine, Atlanta

Univerisity of Kansas Medical Center, Kansas City

Johns Hopkins School of Medicine, Baltimore

Davita Clinical Research, Minneapolis

Mayo Medical Center, Rochester

Rogosin Institute, New York

Northwest Renal Clinic, Portland

Vanderbilt University Medical Center, Nashville

Nephrology Clinical Research Center at the University of Virginia, Charlottesville