Multi-center, Open-label, Extension Study to Evaluate the Long-term Efficacy and Safety of Oral Tolvaptan Tablet Regimens in Subjects with Autosomal Dominant Polycystic Kidney Disease (ADPKD) - ND
- Conditions
- Autosomal Dominant Polycystic Kidney Disease (ADPKD)MedDRA version: 9.1Level: LLTClassification code 10036046
- Registration Number
- EUCTR2010-018401-10-IT
- Lead Sponsor
- OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALISATION INC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1500
1) Successful completion (protocol defined completer without early termination) of a Phase 1, 2, or 3 tolvaptan ADPKD or renal impairment trial, with a confirmed diagnosis of ADPKD. 2) Estimated GFR =30 ml/min/1.73m2 within 30 days prior to enrollment (calculated using the IDMS-traceable modification of diet in renal disease [4 parameter MDRD] equation with correction for gender and race). Subjects with lower estimated GFR (eGFR) may be permitted with documented medical monitor approval prior to enrollment.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
• Safety contraindications including: non-compliance with therapies, reproductive precautions, unawareness of thirst, severe allergic reactions to compounds with similar chemical structure as tolvaptan • Contraindications to or interference with MRI assessments • Concurrent conditions or taking therapies likely to confound endpoint assessments or prevent completion of the trial (Efficacy Analysis Exclusion Only)
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method