A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]

NCT01022424 | Completed Phase 3 Results

• 2 other identifiers: 156-09-003JapicCTI-090948
• Study Type: interventional
• Target: 13
• Locations: 1 country
• Sites: 1

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.

Conditions

Autosomal Dominant Polycystic Kidney Disease

Keywords

ADPKD; Tolvaptan; OPC-41061

Outcome Measures

Primary Outcomes (2)

• 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. 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.

  Baseline, Week 48, 96, 144, and 192

• 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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.

  Baseline, Week 48, 96, 144, and 192

Study Arms (1)

OPC-41061

EXPERIMENTAL

Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Drug: OPC-41061

Interventions

OPC-41061 DRUG

Repeated oral administration at doses of 15 mg twice daily (morning and evening)

OPC-41061

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Otsuka Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Unknown Facility

Kanto Region, Japan

Location

MeSH Terms

Conditions

Polycystic Kidney, Autosomal Dominant

Interventions

Tolvaptan

Condition Hierarchy (Ancestors)

Polycystic Kidney Diseases; Kidney Diseases, Cystic; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Abnormalities, Multiple; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Ciliopathies; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Director of Clinical Trials
• Organization: Otsuka Pharmaceutical Co.,Ltd.

+81-3-6361-7366

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2009
• First Posted: December 1, 2009
• Study Start: November 1, 2009
• Primary Completion: July 1, 2014
• Study Completion: July 1, 2014
• Last Updated: September 11, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-08

Locations

JP (1)