Skip to main content
OpenTrials
Completed

NCT Number: NCT05306210

Forxiga CKD Japan Post-Marketing Surveillance (PMS)

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Research Site, Aichi, Japan

Loading trial locations.

About this study

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.

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • None

Treatment and study plan

Primary outcomes

  1. Incidence of ADRs during use of Forxiga in the real world setting

    Time frame: from baseline of 1year

    To be calculated incidence of ADRs related to Forxiga during the observation period

  2. Incidence of ADRs which are unexpected from the precautions for use in our JPI

    Time frame: 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

  3. Factors (ie demography, treatment) possibly having an impact on the safety

    Time frame: from baseline to 1 year

    Factors which may impact incidence of ADRs analysed by patient demographic characteristic (past medical history and concomitant disease etc)

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 1, 2022
Registry last updated
Oct 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.