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Post-Marketing Surveillance Study of Tolvaptan in Patients With ADPKD

NCT ID: NCT02847624

Last Updated: 2023-12-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1672 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-24

Study Completion Date

2022-09-20

Brief Summary

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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

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Conditions

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Polycystic Kidney, Autosomal Dominant

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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ADPKD

tolvaptan

Intervention Type DRUG

Interventions

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tolvaptan

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* diagnosed ADPKD
* total kidney volume of 750 or more

Exclusion Criteria

\-
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Otsuka Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yasuhiko Fukuta, PhD

Role: STUDY_DIRECTOR

Otsuka Pharmaceutical Co., Ltd.

Locations

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Otsuka Pharmaceutical Co., Ltd.

Tokyo, , Japan

Site Status

Countries

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Japan

References

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Mochizuki T, Muto S, Suzue K, Komaniwa S, Tanaka T, Fukuta Y, Yamashige Y. Safety and efficacy of tolvaptan in real-world Japanese patients with autosomal dominant polycystic kidney disease: final results of SLOW-PKD surveillance. Clin Exp Nephrol. 2025 Jun;29(6):807-817. doi: 10.1007/s10157-025-02634-7. Epub 2025 Feb 14.

Reference Type DERIVED
PMID: 39953249 (View on PubMed)

Other Identifiers

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15600-003

Identifier Type: -

Identifier Source: org_study_id