Kidney Disease, ChronicNCT06287073
JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
An observational study of Kidney Disease, Chronic, run by Boehringer Ingelheim at 12 sites in South Korea.
Trial summary
The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice. The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Kidney Disease, Chronic
- What is being tested?
- JARDIANCE®
- How many people
- 299 participants
- Where
- 12 sitesSouth Korea
- Study dates
- 29 Mar 2024to 30 Apr 2025
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a single-arm, open-label, multi-centre observational and non-interventional study (ONIS) based on newly collected data. This study will be carried out by enrolling patients in a consecutive manner into the study requiring completion of case report forms (CRFs) for all participants who initially administered JARDIANCE® following the study start date until the planned number of participants is reached.
Who may be able to join
- Age ≧19 years at enrolment
- Patients diagnosed with CKD
- Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea
- Patients who have provided informed consent and signed the data release consent form
Who cannot join
- Patients with previous exposure to JARDIANCE®
- Patients with hypersensitivity to empagliflozin or to any of the excipients
- Patients with type 1 diabetes
- Patients with history of Diabetic Ketoacidosis (DKA)
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
- Patients who are pregnant or are breastfeeding or who plan to become pregnant during the study period
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
South Korea12 sites
Hallym University Sacred Heart Hospital
Anyang, 07441
Chungbuk National University Hospital
Cheongiu, 28644
Yonsei University Wonju Severance Christian Hospital
Gangwon, 26426
Inje University Ilsan Paik Hospital
Goyang, 10380
Chonnam National University Hospital
Gwangju, 61469
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, 03312
Soonchunhyang University Hospital Seoul
Seoul, 04401
Samsung Medical Center
Seoul, 06351
The Catholic University of Korea, Yeouido St.Mary's Hospital
Seoul, 07345
Ulsan University Hospital
Ulsan, 44033
About this study
Official title: A Regulatory Non-interventional Study to Monitor the Safety and Efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean Patients With Chronic Kidney Disease (CKD)
The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment.
- 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
JARDIANCE®
| Study group | Role | What they receive |
|---|---|---|
| JARDIANCE® treated patients | Patients with chronic kidney disease (CKD) who started JARDIANCE® for the first time in accordance with the approved label in Korea, treated according to routine clinical practice. Receives: Drug: JARDIANCE® |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants With Adverse Events (AEs)
Number of participants with adverse events (AEs).
Measured: Up to 337 days.
Number of Participants With Serious Adverse Event (SAEs)
Number of participants with serious adverse event (SAEs).
Measured: Up to 337 days.
Number of Participants With Non-serious Adverse Events
Number of participants with non-serious adverse events.
Measured: Up to 337 days.
Number of Participants With Adverse Drug Reaction (ADR)s
Number of participants with adverse drug reaction (ADR)s.
Measured: Up to 337 days.
Number of Participants With Serious Adverse Drug Reactions
Number of participants with serious adverse drug reactions.
Measured: Up to 337 days.
Number of Participants With Unexpected Adverse Events
Number of participants with unexpected adverse events.
Measured: Up to 337 days.
Number of Participants With Adverse Events of Special Interest (AESIs)
Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation.
Measured: Up to 337 days.
Number of Participants With Specific Adverse Events
Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia.
Measured: Up to 337 days.
Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation
Number of participants with adverse events leading to temporary or permanent discontinuation.
Measured: Up to 337 days.
Number of Participants With Adverse Events by Intensity
Number of participants with adverse events by intensity.
Measured: Up to 337 days.
Number of Participants With Adverse Events by Outcome of the Events
Number of participants with adverse events by outcome of the events.
Measured: Up to 337 days.
Number of Participants With Adverse Events by Causality
Number of participants with adverse events by causality.
Measured: Up to 337 days.
Number of Participants With Adverse Events Leading to Death
Number of participants with adverse events leading to death.
Measured: Up to 337 days.
Secondary outcomes (1)
Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment
Change in Urine Albumin-Creatinine Ratio (UACR) from baseline after 12 weeks and 24 weeks of treatment. UACR is calculated as albumin (milligrams)/creatinine (grams)
Measured: Data collected at baseline (visit 1), week 12 and week 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Feb 2024
- Study start29 Mar 2024
- Primary completion30 Apr 2025
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- 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
- 299 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
- NCT06287073
- Sponsor's protocol ID
- 1245-0323
- Other IDs
- EUPAS107293
- Status last verified
- May 2026
- First submitted
- 23 Feb 2024
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https://www.mystudywindow.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 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Regulatory Non-interventional Study to Monitor the Safety and Efficacy of JARDIANCE® (Empagliflozin 10 mg) in Korean Patients With Chronic Kidney Disease (CKD)
- ClinicalTrials.gov ID
- NCT06287073
- Acronym / sponsor ID
- 1245-0323
- Conditions
- Kidney Disease, Chronic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 29 Mar 2024 (actual)
- Primary completion
- 30 Apr 2025 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 29 Feb 2024 (actual)
- Results
- Posted 23 Jun 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| JARDIANCE® treated patients | – | Drug: JARDIANCE®Patients with chronic kidney disease (CKD) who started JARDIANCE® for the first time in accordance with the approved label in Korea, treated according to routine clinical practice. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a single-arm, open-label, multi-centre observational and non-interventional study (ONIS) based on newly collected data. This study will be carried out by enrolling patients in a consecutive manner into the study requiring completion of case report forms (CRFs) for all participants who initially administered JARDIANCE® following the study start date until the planned number of participants is reached.
Key inclusion criteria (4 listed)
- Age ≧19 years at enrolment
- Patients diagnosed with CKD
- Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea
- Patients who have provided informed consent and signed the data release consent form
Key exclusion criteria (6 listed)
- Patients with previous exposure to JARDIANCE®
- Patients with hypersensitivity to empagliflozin or to any of the excipients
- Patients with type 1 diabetes
- Patients with history of Diabetic Ketoacidosis (DKA)
- Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption
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®JARDIANCE® | Drug | JARDIANCE® treated patients |
Primary outcome
Number of Participants With Adverse Events (AEs)
Time frame: Up to 337 days.
Number of participants with adverse events (AEs).
Number of Participants With Serious Adverse Event (SAEs)
Time frame: Up to 337 days.
Number of participants with serious adverse event (SAEs).
Number of Participants With Non-serious Adverse Events
Time frame: Up to 337 days.
Number of participants with non-serious adverse events.
Number of Participants With Adverse Drug Reaction (ADR)s
Time frame: Up to 337 days.
Number of participants with adverse drug reaction (ADR)s.
Number of Participants With Serious Adverse Drug Reactions
Time frame: Up to 337 days.
Number of participants with serious adverse drug reactions.
Number of Participants With Unexpected Adverse Events
Time frame: Up to 337 days.
Number of participants with unexpected adverse events.
Number of Participants With Adverse Events of Special Interest (AESIs)
Time frame: Up to 337 days.
Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation.
Number of Participants With Specific Adverse Events
Time frame: Up to 337 days.
Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia.
Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation
Time frame: Up to 337 days.
Number of participants with adverse events leading to temporary or permanent discontinuation.
Number of Participants With Adverse Events by Intensity
Time frame: Up to 337 days.
Number of participants with adverse events by intensity.
Number of Participants With Adverse Events by Outcome of the Events
Time frame: Up to 337 days.
Number of participants with adverse events by outcome of the events.
Number of Participants With Adverse Events by Causality
Time frame: Up to 337 days.
Number of participants with adverse events by causality.
Number of Participants With Adverse Events Leading to Death
Time frame: Up to 337 days.
Number of participants with adverse events leading to death.
1 secondary outcome
Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment
Time frame: Data collected at baseline (visit 1), week 12 and week 24.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https://www.mystudywindow.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.
12 sites 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 12 sites in South Korea.
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 4 inclusion and 6 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 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in South Korea. 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?
Yes. Results are posted in the registry (first posted 23 Jun 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants With Adverse Events (AEs) (time frame: Up to 337 days.). The study lists 13 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 23 Jun 2026.