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)
Phase 3
Completed
- Conditions
- Genetic disease whereby the kidneys contain multiple cysts filled with fluid1003836010038430
- Registration Number
- NL-OMON39149
- Lead Sponsor
- Covance
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 96
Inclusion Criteria
- Successful completion of a previous phase 1, 2, or 3 tolvaptan ADPKD or renal impairment trial, with a confirmed diagnosis of ADPKD.
- Estimated GFR greater than or equal to 30 mL/min/1.73 m2 within 30 days prior to enrollment, or with documented medical monitor approval prior to enrollment.
Exclusion Criteria
- 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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>For subjects continuing from protocol 156-04-251 comparing those previously<br /><br>treated with tolvaptan (combining all doses) to those subjects previously<br /><br>treated with placebo, disease modification as measured by:<br /><br><br /><br>- Percent change from 156-04-251 baseline in total kidney volume (TKV) at month<br /><br>24 in trial 156-08-271 as compared to the percent change in TKV at 156-04-251<br /><br>Month 36 measured by magnetic resonance imaging (MRI)<br /><br><br /><br>then,<br /><br><br /><br>- Change in renal function (100x1/Serum Creatinine mg/dL) at Month 24 in trial<br /><br>156-08-271 as compared to change from end of titration in renal function at<br /><br>Month 36 in protocol 156-04-251. </p><br>
- Secondary Outcome Measures
Name Time Method <p>In prior placebo subjects enrolling from protocol 156-04-251:<br /><br><br /><br>- Change in annual TKV slope when crossing over to tolvaptan treatment<br /><br>- Change in annual slope for renal function (100x1/Serum Creatinine mg/dL) when<br /><br>crossing over to tolvaptan treatment<br /><br><br /><br>For all subjects enrolled in this trial:<br /><br><br /><br>- Change from baseline in TKV by exposure group<br /><br>- Change from end of titration in renal function (100x1/Serum Creatinine mg/dL)<br /><br>by exposure group<br /><br>- For subjects who are taking anti-hypertensive therapy at Baseline in this<br /><br>trial, percentage with clinically sustained decreases of blood pressure (BP)<br /><br>leading to a sustained reduction in anti-hypertensive therapy compared to<br /><br>Baseline (while taking investigational product) at visit Months 12 and 24 for<br /><br>hypertensive subjects.</p><br>