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

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: Completed
• Conditions: Kidney Disease, Chronic
• Intervention / Treatment: Drug: JARDIANCE®

• Study Type: Observational
• Enrollment (Actual): 299

Contacts and Locations

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

Eligibility Criteria

• 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

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
New JARDIANCE® users with chronic kidney disease (CKD); Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea	Drug: JARDIANCE®; JARDIANCE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of subjects with adverse events		Up to 24 weeks
Number of subjects with serious adverse event		Up to 24 weeks
Number of subjects with non-serious adverse events		Up to 24 weeks
Number of subjects with adverse drug reaction		Up to 24 weeks
Number of subjects with serious adverse drug reactions		Up to 24 weeks
Number of subjects with unexpected adverse events		Up to 24 weeks
Number of subjects with adverse events of special interest	Adverse events of special interest are: liver injury, ketoacidosis in diabetic and nondiabetic population, lower limb amputation	Up to 24 weeks
Number of subjects with specific adverse events	Specific adverse events are: severe hypoglycaemia, urinary tract infection, genital infection, bone fracture, urinary tract malignancy, volume depletion, acute kidney injury, gout, hyperkalaemia	Up to 24 weeks
Number of subjects with adverse events leading to temporary or permanent discontinuation		Up to 24 weeks
Number of subjects with adverse events by intensity	Intensity is measured as: mild, moderate, severe	Up to 24 weeks
Number of subjects with adverse events by outcome of the events	Outcome of the event is measured as: recovered, not yet recovered, sequela, fatal, unknown	Up to 24 weeks
Number of subjects with adverse events by causality	Causality is measured as: certain, probable·likely, possible, unlikely, conditional· unclassified, unassessable·unclassifiable	Up to 24 weeks
Number of subjects with adverse events leading to death		Up to 24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment	at baseline, at Week 12, and at Week 24

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): March 29, 2024
• Primary Completion (Actual): April 30, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: February 23, 2024
• First Submitted That Met QC Criteria: February 23, 2024
• First Posted (Actual): February 29, 2024

Study Record Updates

• Last Update Posted (Actual): January 30, 2026
• Last Update Submitted That Met QC Criteria: January 29, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Pathological Conditions, Signs and Symptoms; Renal Insufficiency, Chronic; Sodium-Glucose Transporter 2 Inhibitors; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Hypoglycemic Agents; empagliflozin
• Other Study ID 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