Overview

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.