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] - Full Text View

Sponsor:	Otsuka Pharmaceutical Co., Ltd.
Information provided by (Responsible Party):	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01280721

Purpose

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).

Condition	Intervention	Phase
Autosomal Dominant Polycystic Kidney Disease （ADPKD)	Drug: tolvaptan	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	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]

Resource links provided by NLM:

Drug Information available for: Tolvaptan

U.S. FDA Resources

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

Primary Outcome Measures:

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 ]

Estimated Enrollment:	150
Study Start Date:	November 2010
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: tolvaptan Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.	Drug: tolvaptan Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.

Eligibility

Ages Eligible for Study:	23 Years to 53 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01280721

Locations

Japan

Chubu Region, Japan

Chugoku Region, Japan

Hokkaido Region, Japan

Kanto Region, Japan

Kinki Region, Japan

Kyushu Region, Japan

Tohoku Region, Japan

Sponsors and Collaborators

Otsuka Pharmaceutical Co., Ltd.

More Information

No publications provided

Responsible Party:	Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier:	NCT01280721 History of Changes
Other Study ID Numbers:	156-10-003, JapicCTI-101362
Study First Received:	December 6, 2010
Last Updated:	April 23, 2012
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:

Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic

ClinicalTrials.gov processed this record on May 23, 2012