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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01022424
• Date of registration: 27/11/2009
• Prospective Registration: No
• Primary sponsor: Otsuka Pharmaceutical Co., Ltd.
• Public 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]
• Scientific 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]
• Date of first enrolment: November 2009
• Target sample size: 13
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01022424
• Study type: Interventional
• Study design: Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
• Phase: Phase 3

Countries of recruitment

Japan

Key inclusion & exclusion 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or those who were withdrawn from the study due to reasons other than occurrence of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



Age minimum: N/A
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Autosomal Dominant Polycystic Kidney Disease

Intervention(s)

Drug: OPC-41061

Primary Outcome(s)

Renal Function Test (eGFR) [Time Frame: Baseline, Week 48, 96, 144, and 192]

Total Kidney Volume [Time Frame: Baseline, Week 48, 96, 144, and 192]

Secondary ID(s)

156-09-003

JapicCTI-090948

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 27/07/2018
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01022424