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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]

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ClinicalTrials.gov Identifier: NCT01280721
Recruitment Status : Completed
First Posted : January 21, 2011
Results First Posted : January 17, 2019
Last Update Posted : January 17, 2019
Sponsor:
Information provided by (Responsible Party):
Otsuka Pharmaceutical Co., Ltd.

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).

Condition or disease Intervention/treatment Phase
Autosomal Dominant Polycystic Kidney Disease (ADPKD) Drug: tolvaptan Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 135 participants
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]
Study Start Date : November 2010
Actual Primary Completion Date : August 2014
Actual Study Completion Date : August 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Kidney Diseases
Drug Information available for: Tolvaptan

Arm Intervention/treatment
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.




Primary Outcome Measures :
  1. Total Kidney Volume [ Time Frame: Baseline, Month12, Month24, and Month36 ]

    Measured values of total kidney volume (sum of the volume of the left and right kidneys) during trial period.

    Twice-daily repeated oral administration of tolvaptan at daily doses of 60 to 120 mg.

    Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.


  2. Renal Function Test (eGFR) [ Time Frame: Baseline, Month12, Month24, and Month36 ]

    Estimated glomerular filtration rate calculated by Japanese equation for eGFR during trial period.

    Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.


  3. Renal Function Test (Cys-C) [ Time Frame: Baseline, Month 12, Month 24, and Month 36 ]
    Measured values of serum cystatin C concentration during trial period. Number of participants analyzed at each time point represents number of participants with data at the specified time point. Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.) are excluded.



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

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
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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.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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 Posted: January 21, 2011    Key Record Dates
Results First Posted: January 17, 2019
Last Update Posted: January 17, 2019
Last Verified: August 2018
Additional relevant MeSH terms:
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Kidney Diseases
Polycystic Kidney Diseases
Polycystic Kidney, Autosomal Dominant
Urologic Diseases
Kidney Diseases, Cystic
Abnormalities, Multiple
Congenital Abnormalities
Ciliopathies
Genetic Diseases, Inborn
Tolvaptan
Antidiuretic Hormone Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Natriuretic Agents
Physiological Effects of Drugs