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

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

      • 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.

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

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.

Clinical Trials on Polycystic Kidney, Autosomal Dominant

Clinical Trials on tolvaptan

3
Subscribe