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

• 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: Otsuka Pharmaceutical Co., Ltd.
• Information provided by (Responsible Party): Otsuka Pharmaceutical Co., Ltd.

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: OPC-41061	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 13 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) (2) [Extension of Study 156-05-002]
• Study Start Date: November 2009
• Actual Primary Completion Date: July 2014
• Actual Study Completion Date: July 2014

Arms and Interventions

Arm	Intervention/treatment
Experimental: OPC-41061; Repeated oral administration at doses of 15 mg twice daily (morning and evening)	Drug: OPC-41061; Repeated oral administration at doses of 15 mg twice daily (morning and evening)

Outcome Measures

Primary Outcome Measures :

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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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

2. 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.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Locations

Japan

Kanto Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

More Information

• Responsible Party: Otsuka Pharmaceutical Co., Ltd.
• ClinicalTrials.gov Identifier: NCT01022424
• Other Study ID Numbers: 156-09-003; JapicCTI-090948 ( Other Identifier: JAPIC )
• First Posted: December 1, 2009
• Results First Posted: July 27, 2018
• Last Update Posted: September 11, 2018
• Last Verified: August 2018

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

ADPKD; Tolvaptan; OPC-41061

Additional relevant MeSH terms:

Arthrogryposis; Kidney Diseases; Polycystic Kidney Diseases; Polycystic Kidney, Autosomal Dominant; Urologic Diseases; Joint Diseases; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Abnormalities; Congenital Abnormalities; Kidney Diseases, Cystic; Abnormalities, Multiple; Ciliopathies; Genetic Diseases, Inborn; Tolvaptan; Antidiuretic Hormone Receptor Antagonists; Molecular Mechanisms of Pharmacological Action; Natriuretic Agents; Physiological Effects of Drugs