Overview
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Status:
Completed
Completed
Trial end date:
2012-01-01
2012-01-01
Target enrollment:
0
0
Participant gender:
All
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 3Accepts Healthy Volunteers?
NoDetails
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.