Forxiga CKD Japan Post-Marketing Surveillance (PMS)
- Conditions
- Chronic Kidney Disease
- Registration Number
- NCT05306210
- Lead Sponsor
- AstraZeneca
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1029
- Patients with CKD except for dialysis and/or renal failure chronic
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of ADRs which are unexpected from the precautions for use in our JPI from baseline to 1 year To be calculated incidence of ADRs related to Forxiga during the observation period not expected from the precautions for use of Forxiga JPI
Incidence of ADRs during use of Forxiga in the real world setting from baseline of 1year To be calculated incidence of ADRs related to Forxiga during the observation period
Factors (ie demography, treatment) possibly having an impact on the safety from baseline to 1 year Factors which may impact incidence of ADRs analysed by patient demographic characteristic (past medical history and concomitant disease etc)
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Research Site
🇯🇵Yamanashi, Japan