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]
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]
2 other identifiers
interventional
135
1 country
7
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2010
Typical duration for phase_3
7 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2010
CompletedFirst Submitted
Initial submission to the registry
December 6, 2010
CompletedFirst Posted
Study publicly available on registry
January 21, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2014
CompletedResults Posted
Study results publicly available
January 17, 2019
CompletedJanuary 17, 2019
August 1, 2018
3.8 years
December 6, 2010
November 12, 2017
August 15, 2018
Conditions
Outcome Measures
Primary Outcomes (3)
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
Baseline, Month12, Month24, and Month36
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 Patients who were withdrawn from trial or have no appropriate data (e.g., interruption of medication, protocol deviation, etc.)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.
Baseline, Month12, Month24, and Month36
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.
Baseline, Month 12, Month 24, and Month 36
Study Arms (1)
tolvaptan
EXPERIMENTALRepeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Interventions
Repeated oral administration twice daily (morning and evening) at one of three split dose-regimens 45mg/15mg, 60mg/30mg or 90mg/30mg.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (7)
Unknown Facility
Chubu Region, Japan
Unknown Facility
Chugoku Region, Japan
Unknown Facility
Hokkaido Region, Japan
Unknown Facility
Kanto Region, Japan
Unknown Facility
Kinki Region, Japan
Unknown Facility
Kyushu Region, Japan
Unknown Facility
Tohoku Region, Japan
Related Publications (1)
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.
PMID: 29123425DERIVED
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Director of Clinical Trials
- Organization
- Otsuka Pharmaceutical Co., LTD.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 6, 2010
First Posted
January 21, 2011
Study Start
November 1, 2010
Primary Completion
August 1, 2014
Study Completion
August 1, 2014
Last Updated
January 17, 2019
Results First Posted
January 17, 2019
Record last verified: 2018-08