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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

299 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-03-29

Study Completion Date

2025-04-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Disease, Chronic

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

JARDIANCE®

Intervention Type DRUG

JARDIANCE®

Interventions

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JARDIANCE®

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No