Forxiga CKD Japan Post-Marketing Surveillance (PMS)

NCT ID: NCT05306210

Last Updated: 2025-10-09

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

1029 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-12

Study Completion Date

2024-10-08

Brief Summary

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To capture safety when Forxige is administrated to CKD patients in the real world setting

Detailed Description

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The purpose of the study is to review the following points during use of Forxiga Tablets (hereinafter referred to as Forxiga) in the real world setting after launch for treatment of CKD.

1. ADRs which are unexpected from the precautions for use in our JPI
2. Understanding of incidence of ADRs during use of Forxiga in the real world setting
3. Factors (ie demography, treatment) possibly having an impact on the safety.

Conditions

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Chronic Kidney Disease

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Patients with CKD except for dialysis and/or renal failure chronic

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AstraZeneca

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Toshimitsu Tokimoto

Role: STUDY_DIRECTOR

Astrazeneca KK

Locations

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Aichi, , Japan

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Akita, , Japan

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Aomori, , Japan

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Chiba, , Japan

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Ehime, , Japan

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Fukui, , Japan

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Fukuoka, , Japan

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Fukushima, , Japan

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Gifu, , Japan

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Gunma, , Japan

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Hiroshima, , Japan

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Hokkaido, , Japan

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Hyōgo, , Japan

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Ibaraki, , Japan

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Ishikawa, , Japan

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Kagawa, , Japan

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Kagoshima, , Japan

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Kanagawa, , Japan

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Kochi, , Japan

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Kumamoto, , Japan

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Kyoto, , Japan

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Mie, , Japan

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Miyagi, , Japan

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Miyazaki, , Japan

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Nagano, , Japan

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Nagasaki, , Japan

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Nara, , Japan

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Niigata, , Japan

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Numakunai, , Japan

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Okayama, , Japan

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Okinawa, , Japan

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Osaka, , Japan

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Ōita, , Japan

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Saga, , Japan

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Saitama, , Japan

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Shiga, , Japan

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Shimane, , Japan

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Shizuoka, , Japan

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Tochigi, , Japan

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Tokushima, , Japan

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Tokyo, , Japan

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Toyama, , Japan

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Wakayama, , Japan

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Yamagata, , Japan

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Yamaguchi, , Japan

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Yamanashi, , Japan

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Countries

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Japan

Other Identifiers

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D169AC00007

Identifier Type: -

Identifier Source: org_study_id

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