JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
- Registration Number
- NCT06287073
- Lead Sponsor
- Boehringer Ingelheim
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 299
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description New JARDIANCE® users with chronic kidney disease (CKD) JARDIANCE® Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea
- Primary Outcome Measures
Name Time Method 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 unexpected adverse events Up to 24 weeks Number of subjects with adverse events of special interest Up to 24 weeks Adverse events of special interest are: liver injury, ketoacidosis in diabetic and nondiabetic population, lower limb amputation
Number of subjects with specific adverse events Up to 24 weeks Specific adverse events are: severe hypoglycaemia, urinary tract infection, genital infection, bone fracture, urinary tract malignancy, volume depletion, acute kidney injury, gout, hyperkalaemia
Number of subjects with non-serious adverse events Up to 24 weeks Number of subjects with serious adverse drug reactions Up to 24 weeks Number of subjects with adverse drug reaction Up to 24 weeks Number of subjects with adverse events by outcome of the events Up to 24 weeks Outcome of the event is measured as: recovered, not yet recovered, sequela, fatal, unknown
Number of subjects with adverse events by causality Up to 24 weeks Causality is measured as: certain, probable·likely, possible, unlikely, conditional· unclassified, unassessable·unclassifiable
Number of subjects with adverse events leading to death 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 Up to 24 weeks Intensity is measured as: mild, moderate, severe
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (10)
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
🇰🇷Seoul, Korea, Republic of
Soonchunhyang University Hospital Seoul
🇰🇷Seoul, Korea, Republic of
Hallym University Sacred Heart Hospital
🇰🇷Anyang, Korea, Republic of
Chungbuk National University Hospital
🇰🇷Cheongiu, Korea, Republic of
Yonsei University Wonju Severance Christian Hospital
🇰🇷Gangwon, Korea, Republic of
Inje University Ilsan Paik Hospital
🇰🇷Goyang, Korea, Republic of
Chonnam National University Hospital
🇰🇷Gwangju, Korea, Republic of
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Ulsan University Hospital
🇰🇷Ulsan, Korea, Republic of