Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD

Completed

• Conditions: Polycystic Kidney, Autosomal Dominant
• Interventions: Drug: tolvaptan

• Registration Number: NCT02847624
• Lead Sponsor: Otsuka Pharmaceutical Co., Ltd.

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-03-24
• Study First Submitted: 2016-07-25
• Study First Submitted QC: 2016-07-25
• Study First Posted: 2016-07-28
• Primary Completion: 2022-09-20
• Study Completion: 2022-09-20
• Status Verified: 2023-12
• Last Update Submitted: 2023-12-24
• Last Update Posted: 2023-12-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1672

Inclusion Criteria

• diagnosed ADPKD
• total kidney volume of 750 or more

Exclusion Criteria

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ADPKD	tolvaptan	-

Primary Outcome Measures

Name	Time	Method
total kidney volume	8 years

Secondary Outcome Measures

Name	Time	Method
liver function	8 years

Trial Locations

Locations (1)

Otsuka Pharmaceutical Co., Ltd.; 🇯🇵 Tokyo, Japan