A multicenter, open-label extension study to investigate the long-term safety and efficacy of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) [Extension of Trial 156-04-251]
- Conditions
- Autosomal dominant polycystic kidney disease (ADPKD)
- Registration Number
- JPRN-jRCT2080221325
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 150
1) Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed.
2) Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251.
3) Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up.
1) Patients with eGFR of less than 15 mL/min/1.73 m2
2) Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
3) Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan
4) Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG<br>Every 1, 3 or 12 months<br>combined renal volume (right and left kidneys) and renal function test<br>Every 3 or 12 months
- Secondary Outcome Measures
Name Time Method