A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

Study Overview
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Brief Summary
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ADPKD patients who were enrolled in Study 156-05-002 will receive repeated oral administration of OPC-41061 at doses of 15 mg twice daily (morning and evening). Administration will be continued until the time of manufacturing and distribution approval of OPC-41061 for ADPKD in Japan.

Official Title
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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
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Autosomal Dominant Polycystic Kidney Disease

Intervention / Treatment
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* Drug: OPC-41061


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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) Patients in whom adverse events occurring in study 156-05-002 were resolved or became stable and do not require further follow-up. Exclusion Criteria: Patients with eGFR of less than 15 mL/min/1.73 m2 Patients with any of the following complications: Uncontrolled hypertension Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis) 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
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OPC-41061<br>Repeated oral administration at doses of 15 mg twice daily (morning and evening) | Drug: OPC-41061<br>* Repeated oral administration at doses of 15 mg twice daily (morning and evening)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total Kidney Volume | Individual subject data on the volumes of the total kidney volume (sum of the volumes of the left and right kidneys) measured by magnetic resonance imaging or computed tomography during trial period. Repeated oral administration at doses of 15 mg twice daily (morning and evening) until approval of the revised protocol (Edition 4.0) by the IRB of each trial site. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Week 48, 96, 144, and 192 | 
| Renal Function Test (eGFR) | Individual subject data on eGFR (estimated glomerular filtration rate calculated by Japanese eGFR equation) during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded. | Baseline, Week 48, 96, 144, and 192 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ADPKD, Tolvaptan, OPC-41061