Kidney Disease, Chronic
Conditions
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.
Interventions
DRUGJARDIANCE®
JARDIANCE®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 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 |
| 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 | — |
Secondary
| 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 |
Countries
South Korea
Outcome results
None listed