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

August 15, 2018 updated by: Otsuka Pharmaceutical Co., Ltd.
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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

17

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Kanto Region, Japan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 1
Drug: OPC-41061
orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline, week 24, 52, 104, and 156
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.
Baseline, Week 24, 48, 104, and 156

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Otsuka Pharmaceutical Co., Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2006

Primary Completion (Actual)

November 1, 2010

Study Completion (Actual)

November 1, 2010

Study Registration Dates

First Submitted

February 9, 2009

First Submitted That Met QC Criteria

February 10, 2009

First Posted (Estimate)

February 11, 2009

Study Record Updates

Last Update Posted (Actual)

September 11, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 156-05-002
  • JapicCTI-090690

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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