Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

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: NCT00841568
Recruitment Status : Completed
First Posted : February 11, 2009
Results First Posted : July 27, 2018
Last Update Posted : September 11, 2018
Sponsor:
Information provided by:
Otsuka Pharmaceutical Co., Ltd.

Tracking Information
First Submitted Date  ICMJE February 9, 2009
First Posted Date  ICMJE February 11, 2009
Results First Submitted Date  ICMJE October 17, 2017
Results First Posted Date  ICMJE July 27, 2018
Last Update Posted Date September 11, 2018
Study Start Date  ICMJE April 2006
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • Total Kidney Volume [ Time Frame: Baseline, week 24, 52, 104, and 156 ]
    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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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) [ Time Frame: Baseline, Week 24, 48, 104, and 156 ]
    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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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: February 10, 2009)
  • Safety: adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG [ Time Frame: 156 weeks ]
  • Efficacy: combined renal volume (right and left kidneys) and renal function test [ Time Frame: 156 weeks ]
  • Pharmacology: urine osmolality [ Time Frame: 156 weeks ]
Change History Complete list of historical versions of study NCT00841568 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) [Extension of Study 156-04-001]
Official Title  ICMJE A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]
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).
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
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
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.
Study Arms  ICMJE Experimental: 1
Intervention: Drug: OPC-41061
Publications * 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.

*   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: February 10, 2009)
17
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 2010
Actual Primary Completion Date November 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
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 NCT00841568
Other Study ID Numbers  ICMJE 156-05-002
JapicCTI-090690
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kyoji Imaoka, Operating Officer, Director, Department of Clinical Research and Development, 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