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

• Status: Completed
• Trial end date: 2010-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
• Collaborator: Otsuka Pharmaceutical Co., Ltd.
• Treatments: Tolvaptan

Criteria

Inclusion Criteria:

• Prior participation in designated tolvaptan ADPKD studies (156-04-248, 156-04-249).

• Able to give Informed Consent.

Exclusion Criteria:

• 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.