Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)

• Status: Completed
• Trial end date: 2012-01-01
• Target enrollment: 0
• Participant gender: All

Summary

This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

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

Criteria

Inclusion Criteria:

• Legal adult age and able to give Informed Consent.

• Adult subjects with a diagnosis of ADPKD. A diagnosis of ADPKD (age 18 or 20-50) required several cysts in each kidney (3 if by sonography, 5 if by CT or MRI) in those with a family history of ADPKD and 10 cysts (by any radiologic method) in each kidney and exclusion of other cystic kidney diseases if there was no family history.

• Willingness to comply with reproductive precautions, if female.

• Estimated creatinine clearance ≥ 60 mL/min. Estimated from serum creatinine during screening using Cockcroft-Gault with correction for gender and race, where possible.

• Rapidly progressive kidney growth (total volume ≥ 750 cc) by magnetic resonance imaging (MRI) at randomization.

Exclusion Criteria:

• Prior exposure to tolvaptan or other experimental PKD therapies.

• Currently taking medication for purpose of affecting PKD cysts.

• 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 or confound study objectives.

• Patients who are unlikely to adequately comply with study procedures.

• Patients having contraindications to MRI.

• Patients taking medications or having any illnesses likely to affect ADPKD outcomes.