Status:
COMPLETED
Tolvaptan Open-label Pilot Efficacy, Tolerability, 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, Autosomal Dominant
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 ...
Detailed Description
Autosomal Dominant Polycystic Kidney Disease is a genetic disease classified by the formation of fluid-filled cysts in the kidneys. The accumulation of these cysts causes the kidneys to enlarge severa...
Eligibility Criteria
Inclusion
- Prior participation in designated tolvaptan ADPKD studies (156-04-248, 156-04-249).
- Able to give Informed Consent.
Exclusion
- 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.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2010
Estimated Enrollment :
46 Patients enrolled
Trial Details
Trial ID
NCT00413777
Start Date
December 1 2005
End Date
June 1 2010
Last Update
July 2 2017
Active Locations (11)
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1
University of Colorado
Denver, Colorado, United States
2
Jacksonville Center for Clinical Research
Jacksonville, Florida, United States
3
Emory University School of Medicine
Atlanta, Georgia, United States
4
Univerisity of Kansas Medical Center
Kansas City, Kansas, United States