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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT01022424

First Posted: December 1, 2009

Last Update Posted: October 19, 2015

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

Purpose

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	Intervention	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: OPC-41061	Phase 3


Study Type:	Interventional
Study Design:	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]

Resource links provided by NLM:

Genetics Home Reference related topics: polycystic kidney disease

MedlinePlus related topics: Kidney Diseases

Drug Information available for: Tolvaptan

U.S. FDA Resources

Further study details as provided by Otsuka Pharmaceutical Co., Ltd.:

Primary Outcome Measures:

combined renal volume (right and left kidneys) and renal function test [ Time Frame: Every 12 or 48 weeks ]
adverse events [ Time Frame: Every 4, 12, or 24 weeks ]


Enrollment:	13
Study Start Date:	November 2009
Study Completion Date:	July 2014
Primary Completion Date:	July 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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)

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:	Child, Adult, Senior
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01022424

Locations


Japan

Kanto Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

More Information


Responsible Party:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01022424 History of Changes
Other Study ID Numbers:	156-09-003 JapicCTI-090948 ( Other Identifier: JAPIC )
First Submitted:	November 27, 2009
First Posted:	December 1, 2009
Last Update Posted:	October 19, 2015
Last Verified:	October 2015

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:


ADPKD Tolvaptan OPC-41061

Additional relevant MeSH terms:


Kidney Diseases Polycystic Kidney Diseases Polycystic Kidney, Autosomal Dominant Urologic Diseases Kidney Diseases, Cystic	Tolvaptan Antidiuretic Hormone Receptor Antagonists Molecular Mechanisms of Pharmacological Action Natriuretic Agents Physiological Effects of Drugs

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