Chronic Kidney DiseaseNCT05306210
Forxiga CKD Japan Post-Marketing Surveillance (PMS)
An observational study of Chronic Kidney Disease, run by AstraZeneca at 46 sites in Japan.
Trial summary
To capture safety when Forxige is administrated to CKD patients in the real world setting Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Chronic Kidney Disease
- How many people
- 1,029 participants
- Where
- 46 sitesJapan
- Study dates
- 12 Apr 2022to 8 Oct 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients who initiate Forxiga treatment for chronic kidney disease aligned with the approved Japanese label for the first time
Who may be able to join
- Patients with CKD except for dialysis and/or renal failure chronic
Who cannot join
- None
Trial locations and contacts
46 sites in 1 country.
46 sites in 1 country
Japan46 sites
Research Site
Aichi
Research Site
Akita
Research Site
Aomori
Research Site
Chiba
Research Site
Ehime
Research Site
Fukui
Research Site
Fukuoka
Research Site
Fukushima
Research Site
Gifu
Research Site
Gunma
Research Site
Hiroshima
Research Site
Hokkaido
Research Site
Hyōgo
Research Site
Ibaraki
Research Site
Ishikawa
Research Site
Kagawa
Research Site
Kagoshima
Research Site
Kanagawa
Research Site
Kochi
Research Site
Kumamoto
Research Site
Kyoto
Research Site
Mie
Research Site
Miyagi
Research Site
Miyazaki
Research Site
Nagano
Research Site
Nagasaki
Research Site
Nara
Research Site
Niigata
Research Site
Numakunai
Research Site
Ōita
Research Site
Okayama
Research Site
Okinawa
Research Site
Osaka
Research Site
Saga
Research Site
Saitama
Research Site
Shiga
Research Site
Shimane
Research Site
Shizuoka
Research Site
Tochigi
Research Site
Tokushima
Research Site
Tokyo
Research Site
Toyama
Research Site
Wakayama
Research Site
Yamagata
Research Site
Yamaguchi
Research Site
Yamanashi
About this study
Official title: Forxiga Tablets 5mg, 10mgGeneral Drug Use-Results Study n in Chronic Kidney Disease (CKD) Patients
To capture safety when Forxige is administrated to CKD patients in the real world setting
Read the 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.
- 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.
- Conditions
- Chronic Kidney Disease
- Medical subject headings
- Renal Insufficiency, Chronic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from baseline of 1year
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
Measured: from baseline to 1 year
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)
Measured: from baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2022
- Study start12 Apr 2022
- Primary completion8 Oct 2024
- Study completion8 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,029 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Toshimitsu Tokimoto, Study director, Astrazeneca KK
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05306210
- Sponsor's protocol ID
- D169AC00007
- Status last verified
- Oct 2025
- First submitted
- 23 Mar 2022
- Last updated
- 9 Oct 2025
- Results posted
- No
- Individual data sharing
- Yes: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
Study at a glance
From the registry record, last updated by the sponsor on 9 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Forxiga Tablets 5mg, 10mgGeneral Drug Use-Results Study n in Chronic Kidney Disease (CKD) Patients
- ClinicalTrials.gov ID
- NCT05306210
- Acronym / sponsor ID
- D169AC00007
- Conditions
- Chronic Kidney Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,029 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 12 Apr 2022 (actual)
- Primary completion
- 8 Oct 2024 (actual)
- Study completion
- 8 Oct 2024 (actual)
- First posted
- 1 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
- 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients who initiate Forxiga treatment for chronic kidney disease aligned with the approved Japanese label for the first time
Key inclusion criteria (1 listed)
- Patients with CKD except for dialysis and/or renal failure chronic
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2025.
- Redacted CSR SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshimitsu Tokimoto study director
Astrazeneca KK
46 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Kidney Disease, run by AstraZeneca at 46 sites in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 46 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of ADRs during use of Forxiga in the real world setting (time frame: from baseline of 1year). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2025.