A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]

This study is ongoing, but not recruiting participants.

Sponsor:

Information provided by (Responsible Party):

Otsuka Pharmaceutical Co., Ltd.

ClinicalTrials.gov Identifier:

NCT01280721

First received: December 6, 2010

Last updated: April 23, 2012

Last verified: April 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	December 6, 2010
Last Updated Date	April 23, 2012
Start Date ^ICMJE	November 2010
Estimated Primary Completion Date	June 2014 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: January 19, 2011)	Number of Participants with Adverse Events as a Measure of Safety and Tolerability [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ] Vital signs (systolic and diastolic blood pressure, pulse rate) [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ] Body weight [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ] Laboratory values (hematology, serum chemistry and urinalysis) [ Time Frame: Every 3 months until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ] Plasma AVP concentration [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ] 12-lead ECG (heart rate, PR interval, QRS interval and QT interval) [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: Yes ] Combined renal volume (right and left kidneys) [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: No ] Renal function (estimated GFR and serum cystatin C) [ Time Frame: Every 3 months until 4 years from the date of initial trial drug administration to the first patient ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01280721 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	A Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Official Title ^ICMJE	A Multicenter, Open-label Extension Study to Investigate the Long-term Safety and Efficacy of Tolvaptan in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Trial 156-04-251 in Japan]
Brief Summary	ADPKD patients who enrolled in Trial 156-04-251 will receive repeated oral administration of tolvaptan twice daily (morning and evening: 45mg/15mg, 60mg/30mg, or 90mg/30mg).
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 3
Study Design ^ICMJE	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Intervention ^ICMJE	Drug: tolvaptan Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Study Arm (s)	Experimental: tolvaptan Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg. Intervention: Drug: tolvaptan
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	150
Estimated Completion Date	June 2014
Estimated Primary Completion Date	June 2014 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: Patients who participated in Trial 156-04-251 in Japan and for whom CRF collection has been completed. Patients who completed 3-year repeated administration and who completed the second follow-up visit or patients whose treatment with the trial drug was interupted due to pregnancy and who completed out the second follow-up visit in Trial 156-04-251. Patients in whom any adverse events occurring in Trial 156-04-251 were resolved orstabilized and require no further follow-up. Exclusion Criteria: Patients with eGFR of less than 15 mL/min/1.73 m2 Pregnant, breast-feeding, or possibly pregnant women or women who are planning to become pregnant Patients who received any investigational drug other than Tolvaptan within 30 days prior to commencement of administration of tolvaptan Any patients who, in the opinion of the principle investigator or subinvestigators, should not participate in the study
Gender	Both
Ages	23 Years to 53 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Japan

Administrative Information
NCT Number ^ICMJE	NCT01280721
Other Study ID Numbers ^ICMJE	156-10-003, JapicCTI-101362
Has Data Monitoring Committee	No
Responsible Party	Otsuka Pharmaceutical Co., Ltd.
Study Sponsor ^ICMJE	Otsuka Pharmaceutical Co., Ltd.
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Otsuka Pharmaceutical Co., Ltd.
Verification Date	April 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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