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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 has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01280721
First Posted: January 21, 2011
Last Update Posted: November 14, 2017
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 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: Intervention Model: Single Group Assignment
Masking: None (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:


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 ]
  • 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 ]
  • Body weight [ Time Frame: Every month until 4 years from the date of initial trial drug administration to the first patient ]
  • 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 ]
  • Plasma AVP concentration [ Time Frame: Every 12 months until 4 years from the date of initial trial drug administration to the first patient ]
  • 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 ]
  • 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 ]
  • 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 ]

Enrollment: 135
Study Start Date: November 2010
Study Completion Date: August 2014
Primary Completion Date: August 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

Information from the National Library of Medicine

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Ages Eligible for Study:   23 Years to 53 Years   (Adult)
Sexes Eligible for Study:   All
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
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): 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

Responsible Party: Otsuka Pharmaceutical Co., Ltd.
ClinicalTrials.gov Identifier: NCT01280721     History of Changes
Other Study ID Numbers: 156-10-003
JapicCTI-101362 ( Other Identifier: Japan Pharmaceutical Information Center )
First Submitted: December 6, 2010
First Posted: January 21, 2011
Last Update Posted: November 14, 2017
Last Verified: October 2015

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