Status:
COMPLETED
Tolvaptan Phase 3 Efficacy and Safety Study in Autosomal Dominant Polycystic Kidney Disease (ADPKD)
Lead Sponsor:
Otsuka Pharmaceutical Development & Commercialization, Inc.
Collaborating Sponsors:
Otsuka Pharmaceutical Co., Ltd.
Conditions:
Polycystic Kidney Disease, Autosomal Dominant
Eligibility:
All Genders
18-50 years
Phase:
PHASE3
Brief Summary
This study's purpose is to evaluate the long-term safety and efficacy of tolvaptan versus placebo in patients with ADPKD.
Detailed Description
This study evaluated whether or not tolvaptan is potentially beneficial, while maintaining an adequate safety profile, by reducing the rate of total kidney volume increase, while impacting the onset, ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
1445 Patients enrolled
Trial Details
Trial ID
NCT00428948
Start Date
January 1 2007
End Date
January 1 2012
Last Update
July 2 2017
Active Locations (133)
Enter a location and click search to find clinical trials sorted by distance.
1
Coastal Clinical Research
Mobile, Alabama, United States, 36608
2
University of South Alabama
Mobile, Alabama, United States, 36617
3
Apex Research of Riverside
Riverside, California, United States, 92503
4
Stanford University Medical Center
Stanford, California, United States, 94305-5114