Forxiga CKD Japan Post-Marketing Surveillance (PMS)

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05306210

Enrollment

1029

Registered

2022-04-01

Start date

2022-04-12

Completion date

2024-10-08

Last updated

2025-10-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

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

Exclusion criteria

* None

Design outcomes

Primary

Measure	Time frame	Description
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
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
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)

Countries

Japan

Outcome results