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NCT05306210 Clinical Trial

Forxiga CKD Japan Post-Marketing Surveillance (PMS)

Chronic Kidney Disease Clinical Trial

Official title:
Forxiga Tablets 5mg, 10mgGeneral Drug Use-Results Study n in Chronic Kidney Disease (CKD) Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT05306210
Other study ID # D169AC00007
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
Start date April 12, 2022
Est. completion date April 16, 2025

Study information
Verified date May 2024
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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

Description:

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.

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1029
Est. completion date April 16, 2025
Est. primary completion date April 16, 2025
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Patients with CKD except for dialysis and/or renal failure chronic Exclusion Criteria: - None

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Japan Research Site Aichi
Japan Research Site Akita
Japan Research Site Aomori
Japan Research Site Chiba
Japan Research Site Ehime
Japan Research Site Fukui
Japan Research Site Fukuoka
Japan Research Site Fukushima
Japan Research Site Gifu
Japan Research Site Gunma
Japan Research Site Hiroshima
Japan Research Site Hokkaido
Japan Research Site Hyogo
Japan Research Site Ibaraki
Japan Research Site Ishikawa
Japan Research Site Iwate
Japan Research Site Kagawa
Japan Research Site Kagoshima
Japan Research Site Kanagawa
Japan Research Site Kochi
Japan Research Site Kumamoto
Japan Research Site Kyoto
Japan Research Site Mie
Japan Research Site Miyagi
Japan Research Site Miyazaki
Japan Research Site Nagano
Japan Research Site Nagasaki
Japan Research Site Nara
Japan Research Site Niigata
Japan Research Site Oita
Japan Research Site Okayama
Japan Research Site Okinawa
Japan Research Site Osaka
Japan Research Site Saga
Japan Research Site Saitama
Japan Research Site Shiga
Japan Research Site Shimane
Japan Research Site Shizuoka
Japan Research Site Tochigi
Japan Research Site Tokushima
Japan Research Site Tokyo
Japan Research Site Toyama
Japan Research Site Wakayama
Japan Research Site Yamagata
Japan Research Site Yamaguchi
Japan Research Site Yamanashi

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of ADRs during use of Forxiga in the real world setting To be calculated incidence of ADRs related to Forxiga during the observation period from baseline of 1year
Primary Incidence of ADRs which are unexpected from the precautions for use in our JPI To be calculated incidence of ADRs related to Forxiga during the observation period not expected from the precautions for use of Forxiga JPI from baseline to 1 year
Primary Factors (ie demography, treatment) possibly having an impact on the safety Factors which may impact incidence of ADRs analysed by patient demographic characteristic (past medical history and concomitant disease etc) from baseline to 1 year
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