Kidney Disease, ChronicNCT06527846
Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
An observational study of Kidney Disease, Chronic, run by Boehringer Ingelheim at 1 site in Japan.
Trial summary
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- JARDIANCE®
- How many people
- 1,024 participants
- Where
- 1 siteJapan
- Study dates
- 22 Oct 2024to 31 Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 with chronic kidney disease (CKD) who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and never been treated with JARDIANCE® Tablets before enrolment.
Who may be able to join
- Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
- Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients With Chronic Kidney Disease in Japan
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.
- Conditions
- Kidney Disease, Chronic
- Being tested
- JARDIANCE®
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
JARDIANCE®Drug
Also called Empagliflozin
JARDIANCE®
| Study group | Role | What they receive |
|---|---|---|
| Patients with chronic kidney disease (CKD) | Not described Receives: Drug: JARDIANCE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Drug Reactions (ADRs)
Measured: Up to 52 weeks
Secondary outcomes (5)
Kidney disease progression
Kidney disease progression defined as incidence of end stage kidney disease (ESKD), a sustained decline in estimated glomerular filtration rate (eGFR) to <10 mL/min/1.73 m^2, renal death, or a sustained decline of ≥40% in eGFR from baseline).
ESKD is defined as the initiation of maintenance dialysis or receipt of a kidney transplant.
Measured: Up to 52 weeks
Incidence of cardiovascular death
Measured: Up to 52 weeks
Incidence of all cause death
Measured: Up to 52 weeks
Incidence of hospitalization for heart failure
Measured: Up to 52 weeks
Change from baseline in eGFR to the last observation on treatment
Measured: at baseline, at last observation on treatment (Up to 52 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2024
- Study start22 Oct 2024
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Disease, ChronicStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe 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
- 1,024 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06527846
- Sponsor's protocol ID
- 1245-0340
- Status last verified
- Mar 2026
- First submitted
- 26 Jul 2024
- Last updated
- 19 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post Marketing Surveillance on Long Term Use of JARDIANCE® Tablets in Patients With Chronic Kidney Disease in Japan
- ClinicalTrials.gov ID
- NCT06527846
- Acronym / sponsor ID
- 1245-0340
- Conditions
- Kidney Disease, Chronic
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,024 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 22 Oct 2024 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 30 Jul 2024 (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.
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with chronic kidney disease (CKD) | – | Drug: JARDIANCE® |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with chronic kidney disease (CKD) who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and never been treated with JARDIANCE® Tablets before enrolment.
Key inclusion criteria (2 listed)
- Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
- Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.
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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| JARDIANCE®Also: EmpagliflozinJARDIANCE® | Drug | Patients with chronic kidney disease (CKD) |
Primary outcome
Incidence of Adverse Drug Reactions (ADRs)
Time frame: Up to 52 weeks
5 secondary outcomes
Kidney disease progression
Time frame: Up to 52 weeks
Incidence of cardiovascular death
Time frame: Up to 52 weeks
Incidence of all cause death
Time frame: Up to 52 weeks
Incidence of hospitalization for heart failure
Time frame: Up to 52 weeks
Change from baseline in eGFR to the last observation on treatment
Time frame: at baseline, at last observation on treatment (Up to 52 weeks)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Disease, Chronic, run by Boehringer Ingelheim at 1 site 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 2 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: under way, not looking for participants, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
This study is still under way. Results are not available in the source record yet.
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 Adverse Drug Reactions (ADRs) (time frame: Up to 52 weeks). 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 19 Mar 2026.