A long-term administration study of OPC-41061 in patients with autosomal dominant polycystic kidney disease (ADPKD) (2) [Extension of study 156-05-002]
- Conditions
- Autosomal dominant polycystic kidney disease (ADPKD)
- Registration Number
- JPRN-jRCT2080220916
- Lead Sponsor
- Otsuka Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 15
1) Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the preceding study (156-05-002)
2) Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up.
1) Patients with eGFR of less than 15 mL/min/1.73 m2
2) Patients with any of the following complications
- Uncontrolled hypertension
- Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)
3) Patients with any of the following complications or history thereof
- Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity
- Inability to personally give consent due to a mental illness
4) Patients with SBP (in sitting position) <90 mm Hg
5) Patients with a history of massive bleeding or bleeding tendency
6) Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
7) Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant
8) Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
9) Any patient 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 Safety: adverse events, pre-treatment adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG<br><br>Every 4, 12, or 24 weeks<br><br>Efficacy: combined renal volume (right and left kidneys) and renal function test<br><br>Every 12 or 48 weeks
- Secondary Outcome Measures
Name Time Method