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

Boehringer Ingelheim

Status: Completed

Conditions: Kidney Disease, Chronic

Treatments: Drug: JARDIANCE®

Study type: Observational

Funder types: Industry

Identifiers

NCT06287073

1245-0323

EUPAS107293 (Registry Identifier)

Details and patient eligibility

About

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.

Enrollment: 299 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

299 participants in 1 patient group

New JARDIANCE® users with chronic kidney disease (CKD)

Description:

Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea

Treatment:

Drug: JARDIANCE®