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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
  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 19, 2013