Back to resultsA 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]
Primary Purpose
Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
tolvaptan
Sponsored by
About this trial
This is an interventional treatment trial for Autosomal Dominant Polycystic Kidney Disease （ADPKD)
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
tolvaptan
Arm Description
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Outcomes
Primary Outcome Measures
Total Kidney Volume
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
Renal Function Test (eGFR)
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
Renal Function Test (Cys-C)
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01280721
First Posted
December 6, 2010
Last Updated
August 15, 2018
Sponsor
Otsuka Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT01280721
Brief Title
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
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 Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 2010 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Otsuka Pharmaceutical Co., Ltd.
4. Oversight
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autosomal Dominant Polycystic Kidney Disease （ADPKD)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
135 (Actual)
8. Arms, Groups, and Interventions
Arm Title
tolvaptan
Arm Type
Experimental
Arm Description
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Intervention Type
Drug
Intervention Name(s)
tolvaptan
Intervention Description
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Primary Outcome Measure Information:
Title
Total Kidney Volume
Description
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.
Time Frame
Baseline, Month12, Month24, and Month36
Title
Renal Function Test (eGFR)
Description
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.
Time Frame
Baseline, Month12, Month24, and Month36
Title
Renal Function Test (Cys-C)
Description
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.
Time Frame
Baseline, Month 12, Month 24, and Month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
23 Years
Maximum Age & Unit of Time
53 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
City
Chubu Region
Country
Japan
City
Chugoku Region
Country
Japan
City
Hokkaido Region
Country
Japan
City
Kanto Region
Country
Japan
City
Kinki Region
Country
Japan
City
Kyushu Region
Country
Japan
City
Tohoku Region
Country
Japan
12. IPD Sharing Statement
Citations:
PubMed Identifier
29123425
Citation
Muto S, Okada T, Yasuda M, Tsubouchi H, Nakajima K, Horie S. Long-term safety profile of tolvaptan in autosomal dominant polycystic kidney disease patients: TEMPO Extension Japan Trial. Drug Healthc Patient Saf. 2017 Oct 25;9:93-104. doi: 10.2147/DHPS.S142825. eCollection 2017. Erratum In: Drug Healthc Patient Saf. 2018 Jul 16;10:67-68.
Results Reference
derived
Learn more about this trial
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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