Clinical trial NCT05306210: Forxiga CKD Japan Post-Marketing Surveillance (PMS)
Official title: Forxiga Tablets 5mg, 10mgGeneral Drug Use-Results Study n in Chronic Kidney Disease (CKD) Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Chronic Kidney Disease
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2022-04-01
Enrollment: 1029
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who initiate Forxiga treatment for chronic kidney disease aligned with the approved Japanese label for the first time

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

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: Incidence of ADRs during use of Forxiga in the real world setting
timeFrame: from baseline of 1year
measure: Incidence of ADRs which are unexpected from the precautions for use in our JPI
timeFrame: from baseline to 1 year
measure: Factors (ie demography, treatment) possibly having an impact on the safety
timeFrame: from baseline to 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Aichi
country: Japan
facility: Research Site
city: Akita
country: Japan
facility: Research Site
city: Aomori
country: Japan
facility: Research Site
city: Chiba
country: Japan
facility: Research Site
city: Ehime
country: Japan
facility: Research Site
city: Fukui
country: Japan
facility: Research Site
city: Fukuoka
country: Japan
facility: Research Site
city: Fukushima
country: Japan
facility: Research Site
city: Gifu
country: Japan
facility: Research Site
city: Gunma
country: Japan
facility: Research Site
city: Hiroshima
country: Japan
facility: Research Site
city: Hokkaido
country: Japan
facility: Research Site
city: Hyogo
country: Japan
facility: Research Site
city: Ibaraki
country: Japan
facility: Research Site
city: Ishikawa
country: Japan
facility: Research Site
city: Iwate
country: Japan
facility: Research Site
city: Kagawa
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kanagawa
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kumamoto
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Mie
country: Japan
facility: Research Site
city: Miyagi
country: Japan
facility: Research Site
city: Miyazaki
country: Japan
facility: Research Site
city: Nagano
country: Japan
facility: Research Site
city: Nagasaki
country: Japan
facility: Research Site
city: Nara
country: Japan
facility: Research Site
city: Niigata
country: Japan
facility: Research Site
city: Oita
country: Japan
facility: Research Site
city: Okayama
country: Japan
facility: Research Site
city: Okinawa
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Saga
country: Japan
facility: Research Site
city: Saitama
country: Japan
facility: Research Site
city: Shiga
country: Japan
facility: Research Site
city: Shimane
country: Japan
facility: Research Site
city: Shizuoka
country: Japan
facility: Research Site
city: Tochigi
country: Japan
facility: Research Site
city: Tokushima
country: Japan
facility: Research Site
city: Tokyo
country: Japan
facility: Research Site
city: Toyama
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Yamagata
country: Japan
facility: Research Site
city: Yamaguchi
country: Japan
facility: Research Site
city: Yamanashi
country: Japan
facility: Research Site
Study officials:
affiliation: Astrazeneca KK
name: Toshimitsu Tokimoto
role: STUDY_DIRECTOR
References: