JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)

May 27, 2026 updated by: Boehringer Ingelheim

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
299

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • South Korea
      • Anyang, South Korea, 07441
        • Hallym University Sacred Heart Hospital
      • Cheongiu, South Korea, 28644
        • Chungbuk National University Hospital
      • Gangwon, South Korea, 26426
        • Yonsei University Wonju Severance Christian Hospital
      • Goyang, South Korea, 10380
        • Inje University Ilsan Paik Hospital
      • Gwangju, South Korea, 61469
        • Chonnam National University Hospital
      • Seoul, South Korea, 03080
        • Seoul National University Hospital
      • Seoul, South Korea, 06351
        • Samsung Medical Center
      • Seoul, South Korea, 04401
        • Soonchunhyang University Hospital Seoul
      • Seoul, South Korea, 02841
        • Korea University Anam Hospital
      • Seoul, South Korea, 07345
        • The Catholic University of Korea, Yeouido St.Mary's Hospital
      • Seoul, South Korea, 03312
        • The Catholic University of Korea, Eunpyeong St. Mary's Hospital
      • Ulsan, South Korea, 44033
        • Ulsan University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: JARDIANCE®
JARDIANCE®

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants With Adverse Events (AEs)
Time Frame: Up to 337 days.
Number of participants with adverse events (AEs).
Up to 337 days.
Number of Participants With Serious Adverse Event (SAEs)
Time Frame: Up to 337 days.
Number of participants with serious adverse event (SAEs).
Up to 337 days.
Number of Participants With Non-serious Adverse Events
Time Frame: Up to 337 days.
Number of participants with non-serious adverse events.
Up to 337 days.
Number of Participants With Adverse Drug Reaction (ADR)s
Time Frame: Up to 337 days.
Number of participants with adverse drug reaction (ADR)s.
Up to 337 days.
Number of Participants With Serious Adverse Drug Reactions
Time Frame: Up to 337 days.
Number of participants with serious adverse drug reactions.
Up to 337 days.
Number of Participants With Unexpected Adverse Events
Time Frame: Up to 337 days.
Number of participants with unexpected adverse events.
Up to 337 days.
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.
Up to 337 days.
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.
Up to 337 days.
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.
Up to 337 days.
Number of Participants With Adverse Events by Intensity
Time Frame: Up to 337 days.
Number of participants with adverse events by intensity.
Up to 337 days.
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.
Up to 337 days.
Number of Participants With Adverse Events by Causality
Time Frame: Up to 337 days.
Number of participants with adverse events by causality.
Up to 337 days.
Number of Participants With Adverse Events Leading to Death
Time Frame: Up to 337 days.
Number of participants with adverse events leading to death.
Up to 337 days.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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)
Data collected at baseline (visit 1), week 12 and week 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 29, 2024

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2025

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 30, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 23, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 23, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 29, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 27, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1245-0323
  • EUPAS107293 (Registry Identifier: EU PAS Register)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents upon signing of a 'Document Sharing Agreement'. For study data 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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