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.
Study Type
OBSERVATIONAL
Enrollment
299
JARDIANCE®
Hallym University Sacred Heart Hospital
Anyang, South Korea
Chungbuk National University Hospital
Cheongiu, South Korea
Yonsei University Wonju Severance Christian Hospital
Gangwon, South Korea
Number of subjects with adverse events
Time frame: Up to 24 weeks
Number of subjects with serious adverse event
Time frame: Up to 24 weeks
Number of subjects with non-serious adverse events
Time frame: Up to 24 weeks
Number of subjects with adverse drug reaction
Time frame: Up to 24 weeks
Number of subjects with serious adverse drug reactions
Time frame: Up to 24 weeks
Number of subjects with unexpected adverse events
Time frame: Up to 24 weeks
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
Time frame: Up to 24 weeks
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
Time frame: Up to 24 weeks
Number of subjects with adverse events leading to temporary or permanent discontinuation
Time frame: Up to 24 weeks
Number of subjects with adverse events by intensity
Intensity is measured as: mild, moderate, severe
Time frame: Up to 24 weeks
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Inje University Ilsan Paik Hospital
Goyang, South Korea
Chonnam National University Hospital
Gwangju, South Korea
Korea University Anam Hospital
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
The Catholic University of Korea, Eunpyeong St. Mary's Hospital
Seoul, South Korea
Soonchunhyang University Hospital Seoul
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
...and 2 more locations
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
Time frame: Up to 24 weeks
Number of subjects with adverse events by causality
Causality is measured as: certain, probable·likely, possible, unlikely, conditional· unclassified, unassessable·unclassifiable
Time frame: Up to 24 weeks
Number of subjects with adverse events leading to death
Time frame: Up to 24 weeks
Occurrence of change in urine albumin-creatinine ratio (UACR) from baseline after 12 weeks and/or 24 weeks of treatment
Time frame: at baseline, at Week 12, and at Week 24