Back to resultsA Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease
Status
Completed
Phase
Phase 2
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
Eligibility Criteria
Inclusion Criteria:
- Patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
- Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
Exclusion Criteria:
- Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
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 thereto)
- Inability to personally give consent due to a mental disease "
- Patients with SBP (in sitting position) <90 mm Hg (at screening examination)
- Patients with history of massive bleeding or bleeding tendency
- Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
- Pregnant women, lactating women, or women who may become or plan to become pregnant
- Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
- Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
1
Arm Description
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.
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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
NCT00841568
First Posted
February 9, 2009
Last Updated
August 15, 2018
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT00841568
Brief Title
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Official Title
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
April 2006 (undefined)
Primary Completion Date
November 2010 (Actual)
Study Completion Date
November 2010 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
Detailed Description
Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).
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
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
17 (Actual)
8. Arms, Groups, and Interventions
Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
OPC-41061
Intervention Description
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
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.
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 24, 52, 104, and 156
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 24, 48, 104, and 156
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)
Exclusion Criteria:
Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
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 thereto)
Inability to personally give consent due to a mental disease "
Patients with SBP (in sitting position) <90 mm Hg (at screening examination)
Patients with history of massive bleeding or bleeding tendency
Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
Pregnant women, lactating women, or women who may become or plan to become pregnant
Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Facility Information:
City
Kanto Region
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
21903984
Citation
Higashihara E, Torres VE, Chapman AB, Grantham JJ, Bae K, Watnick TJ, Horie S, Nutahara K, Ouyang J, Krasa HB, Czerwiec FS; TEMPOFormula and 156-05-002 Study Investigators. Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience. Clin J Am Soc Nephrol. 2011 Oct;6(10):2499-507. doi: 10.2215/CJN.03530411. Epub 2011 Sep 8.
Results Reference
derived
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A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
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