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

Phase 2

Completed

• Conditions: Autosomal Dominant Polycystic Kidney Disease
• Interventions: Drug: OPC-41061

• Registration Number: NCT00841568
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

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 Timeline

• Study Start: 2006-04
• Study First Submitted: 2009-02-09
• Study First Submitted QC: 2009-02-10
• Study First Posted: 2009-02-11
• Primary Completion: 2010-11
• Study Completion: 2010-11
• Results First Submitted: 2017-10-17
• Results First Submitted QC: 2017-10-17
• Results First Posted: 2018-07-27
• Status Verified: 2018-08
• Last Update Submitted: 2018-08-15
• Last Update Posted: 2018-09-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 17

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	OPC-41061	-

Primary Outcome Measures

Name	Time	Method
Total Kidney Volume	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)	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.