- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02847624
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD
December 24, 2023 updated by: Otsuka Pharmaceutical Co., Ltd.
Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD in Japan
The purpose of this study is to evaluate the safety and effectiveness of tolvaptan in patients with autosomal dominant polycystic kidney disease (ADPKD) in the real world clinical setting in Japan.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
1672
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Tokyo, Japan
- Otsuka Pharmaceutical Co., Ltd.
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Non-Probability Sample
Study Population
medical institutes all over Japan
Description
Inclusion Criteria:
- diagnosed ADPKD
- total kidney volume of 750 or more
Exclusion Criteria:
-
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
ADPKD
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
total kidney volume
Time Frame: 8 years
|
8 years
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
liver function
Time Frame: 8 years
|
8 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Yasuhiko Fukuta, PhD, Otsuka Pharmaceutical Co., Ltd.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 24, 2014
Primary Completion (Actual)
September 20, 2022
Study Completion (Actual)
September 20, 2022
Study Registration Dates
First Submitted
July 25, 2016
First Submitted That Met QC Criteria
July 25, 2016
First Posted (Estimated)
July 28, 2016
Study Record Updates
Last Update Posted (Actual)
December 27, 2023
Last Update Submitted That Met QC Criteria
December 24, 2023
Last Verified
December 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Kidney Diseases
- Urologic Diseases
- Congenital Abnormalities
- Genetic Diseases, Inborn
- Abnormalities, Multiple
- Kidney Diseases, Cystic
- Ciliopathies
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Urogenital Diseases
- Male Urogenital Diseases
- Polycystic Kidney Diseases
- Polycystic Kidney, Autosomal Dominant
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Natriuretic Agents
- Antidiuretic Hormone Receptor Antagonists
- Tolvaptan
Other Study ID Numbers
- 15600-003
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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