A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

Study Description

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Brief Summary:

Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).

Condition or disease	Intervention/treatment	Phase
Autosomal Dominant Polycystic Kidney Disease	Drug: OPC-41061	Phase 2

Detailed Description:

Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	17 participants
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) [Extension of Study 156-04-001]
Study Start Date :	April 2006
Actual Primary Completion Date :	November 2010
Actual Study Completion Date :	November 2010

Arms and Interventions

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Arm	Intervention/treatment
Experimental: 1	Drug: OPC-41061; orally administered at 15 mg twice daily (morning and evening) for a maximum of 3 years.

Outcome Measures

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Primary Outcome Measures :

1. Safety: adverse events, laboratory values, plasma AVP concentration, vital signs, body weight, and ECG [ Time Frame: 156 weeks ]
2. Efficacy: combined renal volume (right and left kidneys) and renal function test [ Time Frame: 156 weeks ]
3. Pharmacology: urine osmolality [ Time Frame: 156 weeks ]

Eligibility Criteria

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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 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
• Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)

Exclusion Criteria:

• Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination

• 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 thereto)
  • Inability to personally give consent due to a mental disease "
• Patients with SBP (in sitting position) <90 mm Hg (at screening examination)
• Patients with history of massive bleeding or bleeding tendency
• Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
• Pregnant women, lactating women, or women who may become or plan to become pregnant
• Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
• Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study

Contacts and Locations

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Locations

Japan
Kanto Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

More Information

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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Higashihara E, Torres VE, Chapman AB, Grantham JJ, Bae K, Watnick TJ, Horie S, Nutahara K, Ouyang J, Krasa HB, Czerwiec FS; TEMPOFormula and 156-05-002 Study Investigators. Tolvaptan in autosomal dominant polycystic kidney disease: three years' experience. Clin J Am Soc Nephrol. 2011 Oct;6(10):2499-507. doi: 10.2215/CJN.03530411. Epub 2011 Sep 8.

Responsible Party:	Kyoji Imaoka, Operating Officer, Director, Department of Clinical Research and Development, Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT00841568 History of Changes
Other Study ID Numbers:	156-05-002; JapicCTI-090690
First Posted:	February 11, 2009
Last Update Posted:	April 11, 2011
Last Verified:	April 2011

Keywords provided by Otsuka Pharmaceutical Co., Ltd.:

ADPKD; Tolvaptan

Additional relevant MeSH terms:

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