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

Kidney Disease, Chronic Clinical Trial

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)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06287073
• Other study ID #: 1245-0323
• Secondary ID: EUPAS107293
• Status: Recruiting
• Start date: March 29, 2024
• Est. completion date: November 22, 2025

Study information

• Verified date: April 2024
• Source: Boehringer Ingelheim
• Contact: Boehringer Ingelheim
• Phone: 1-800-243-0127
• Email: clintriage.rdg[@]boehringer-ingelheim.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: November 22, 2025
• Est. primary completion date: August 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

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 on dialysis
• 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

Related Conditions & MeSH terms

• Kidney Disease, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• JARDIANCE®
JARDIANCE®

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subjects with adverse events		Up to 24 weeks
Primary	Number of subjects with serious adverse event		Up to 24 weeks
Primary	Number of subjects with non-serious adverse events		Up to 24 weeks
Primary	Number of subjects with adverse drug reaction		Up to 24 weeks
Primary	Number of subjects with serious adverse drug reactions		Up to 24 weeks
Primary	Number of subjects with unexpected adverse events		Up to 24 weeks
Primary	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
Primary	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
Primary	Number of subjects with adverse events leading to temporary or permanent discontinuation		Up to 24 weeks
Primary	Number of subjects with adverse events by intensity	Intensity is measured as: mild, moderate, severe	Up to 24 weeks
Primary	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
Primary	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
Primary	Number of subjects with adverse events leading to death		Up to 24 weeks
Secondary	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

External Links

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