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

Completed · Phase 2

Conditions studied: Polycystic Kidney, Autosomal Dominant

In brief

This study's purpose is to evaluate the long-term safety of open-label tolvaptan regimens to determine the maximally-tolerated dose and acquire pilot efficacy data in patients with autosomal dominant polycystic kidney disease (ADPKD).

Key facts

Study ID

NCT00413777

Run by

Otsuka Pharmaceutical Development & Commercialization, Inc.

People needed

46

Starts

2005-12-01

Expected to finish

2010-06-01

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Prior participation in designated tolvaptan ADPKD studies (156-04-248, 156-04-249).
• Able to give Informed Consent.

You may not qualify if…

• Women who are breast feeding and females of childbearing potential who are not using acceptable contraceptive methods.
• In the opinion of the study investigator or sponsor may present a safety risk.
• Patients who are unlikely to adequately comply with study procedures.
• Patients who at Day 1 have an estimated glomerular filtration rate (GFR) below 30 mL/min or who anticipate renal-replacement therapy within one year of study entry.
• Patients having contraindications to magnetic resonance imaging (MRI) or gadolinium contrast will be eligible but will not be able to participate in MRI.
• Patients taking a diuretic within 1 week of enrollment or likely to need diuretic therapy prior to Month 2.

Where it is running

• University of Colorado — Denver, Colorado, United States
• Jacksonville Center for Clinical Research — Jacksonville, Florida, United States
• Emory University School of Medicine — Atlanta, Georgia, United States
• Univerisity of Kansas Medical Center — Kansas City, Kansas, United States
• Johns Hopkins School of Medicine — Baltimore, Maryland, United States
• Davita Clinical Research — Minneapolis, Minnesota, United States
• Mayo Medical Center — Rochester, Minnesota, United States
• Rogosin Institute — New York, New York, United States
• Northwest Renal Clinic — Portland, Oregon, United States
• Vanderbilt University Medical Center — Nashville, Tennessee, United States
• Nephrology Clinical Research Center at the University of Virginia — Charlottesville, Virginia, United States

Full record on ClinicalTrials.gov

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