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

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.

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Key information

Conditions

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

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Kanto Region, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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Patients who completed 3-year repeated administrations and the follow-up observation or those who were withdrawn from the study due to reasons other than occurrence of adverse events (based on the judgment of either the subject or the investigator/subinvestigator) in the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

Treatment and study plan

OPC-41061

Drug

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

Primary outcomes

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.
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.

Sponsors and collaborators

Lead sponsor

Otsuka Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start: 2009
Primary completion: 2014
Study completion: 2014
First posted: Dec 1, 2009
Registry last updated: Sep 11, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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