Back to resultsA Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
OPC-41061
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease focused on measuring ADPKD, Tolvaptan, OPC-41061
Eligibility Criteria
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- Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
OPC-41061
Arm Description
Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Outcomes
Primary Outcome Measures
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01022424
First Posted
November 27, 2009
Last Updated
August 15, 2018
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01022424
Brief Title
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
Official Title
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
July 2014 (Actual)
Study Completion Date
July 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease
Keywords
ADPKD, Tolvaptan, OPC-41061
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
13 (Actual)
8. Arms, Groups, and Interventions
Arm Title
OPC-41061
Arm Type
Experimental
Arm Description
Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Intervention Type
Drug
Intervention Name(s)
OPC-41061
Intervention Description
Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Primary Outcome Measure Information:
Title
Total Kidney Volume
Description
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.
Time Frame
Baseline, Week 48, 96, 144, and 192
Title
Renal Function Test (eGFR)
Description
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.
Time Frame
Baseline, Week 48, 96, 144, and 192
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
City
Kanto Region
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
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