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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]

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01022424
Recruitment Status : Completed
First Posted : December 1, 2009
Results First Posted : July 27, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE November 27, 2009
First Posted Date  ICMJE December 1, 2009
Results First Submitted Date  ICMJE October 19, 2017
Results First Posted Date  ICMJE July 27, 2018
Last Update Posted Date September 11, 2018
Study Start Date  ICMJE November 2009
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Total Kidney Volume [ Time Frame: Baseline, Week 48, 96, 144, and 192 ]
    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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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) [ Time Frame: Baseline, Week 48, 96, 144, and 192 ]
    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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 30, 2009)
  • combined renal volume (right and left kidneys) and renal function test [ Time Frame: Every 12 or 48 weeks ]
  • adverse events [ Time Frame: Every 4, 12, or 24 weeks ]
Change History Complete list of historical versions of study NCT01022424 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE 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  ICMJE A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Autosomal Dominant Polycystic Kidney Disease
Intervention  ICMJE Drug: OPC-41061
Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Study Arms  ICMJE Experimental: OPC-41061
Repeated oral administration at doses of 15 mg twice daily (morning and evening)
Intervention: Drug: OPC-41061
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 16, 2015)
13
Original Estimated Enrollment  ICMJE
 (submitted: November 30, 2009)
15
Actual Study Completion Date  ICMJE July 2014
Actual Primary Completion Date July 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01022424
Other Study ID Numbers  ICMJE 156-09-003
JapicCTI-090948 ( Other Identifier: JAPIC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Otsuka Pharmaceutical Co., Ltd.
Study Sponsor  ICMJE Otsuka Pharmaceutical Co., Ltd.
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Otsuka Pharmaceutical Co., Ltd.
Verification Date August 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP