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 Participants With Adverse Events (AEs)
Number of participants with adverse events (AEs).
Time frame: Up to 337 days.
Number of Participants With Serious Adverse Event (SAEs)
Number of participants with serious adverse event (SAEs).
Time frame: Up to 337 days.
Number of Participants With Non-serious Adverse Events
Number of participants with non-serious adverse events.
Time frame: Up to 337 days.
Number of Participants With Adverse Drug Reaction (ADR)s
Number of participants with adverse drug reaction (ADR)s.
Time frame: Up to 337 days.
Number of Participants With Serious Adverse Drug Reactions
Number of participants with serious adverse drug reactions.
Time frame: Up to 337 days.
Number of Participants With Unexpected Adverse Events
Number of participants with unexpected adverse events.
Time frame: Up to 337 days.
Number of Participants With Adverse Events of Special Interest (AESIs)
Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation.
Time frame: Up to 337 days.
Number of Participants With Specific Adverse Events
Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
Time frame: Up to 337 days.
Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation
Number of participants with adverse events leading to temporary or permanent discontinuation.
Time frame: Up to 337 days.
Number of Participants With Adverse Events by Intensity
Number of participants with adverse events by intensity.
Time frame: Up to 337 days.
Number of Participants With Adverse Events by Outcome of the Events
Number of participants with adverse events by outcome of the events.
Time frame: Up to 337 days.
Number of Participants With Adverse Events by Causality
Number of participants with adverse events by causality.
Time frame: Up to 337 days.
Number of Participants With Adverse Events Leading to Death
Number of participants with adverse events leading to death.
Time frame: Up to 337 days.
Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment
Change in Urine Albumin-Creatinine Ratio (UACR) from baseline after 12 weeks and 24 weeks of treatment. UACR is calculated as albumin (milligrams)/creatinine (grams)
Time frame: Data collected at baseline (visit 1), week 12 and week 24.