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Clinical Trial Details

Trial ID: L0143
Source ID: NCT06287073
Associated Drug: Jardiance®
Title: JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD)
Acronym:
Status: ACTIVE_NOT_RECRUITING
Study Results: NO
Results:
Conditions: Kidney Disease, Chronic
Interventions: DRUG: JARDIANCE®
Outcome Measures: Primary: 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, Adverse events of special interest are: liver injury, ketoacidosis in diabetic and nondiabetic population, lower limb amputation, 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, 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, Intensity is measured as: mild, moderate, severe, Up to 24 weeks|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, 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, Up to 24 weeks|Number of subjects with adverse events leading to death, Up to 24 weeks | Secondary: 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
Sponsor/Collaborators: Sponsor: Boehringer Ingelheim
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases:
Enrollment: 299
Study Type: OBSERVATIONAL
Study Designs: Observational Model: |Time Perspective: p
Start Date: 2024-03-29
Completion Date: 2025-04-30
Results First Posted:
Last Update Posted: 2025-04-18
Locations: Hallym University Sacred Heart Hospital, Anyang, 14068, Korea, Republic of|Chungbuk National University Hospital, Cheongju, 28644, Korea, Republic of|Inje University Ilsan Paik Hospital, Goyang, 10380, Korea, Republic of|Chonnam National University Hospital, Gwangju, 61469, Korea, Republic of|Korea University Anam Hospital, Seoul, 02841, Korea, Republic of|Samsung Medical Center, Seoul, 03181, Korea, Republic of|The Chatholic University of Korea, Eunpyeong St. Mary's Hospital, Seoul, 03312, Korea, Republic of|Seoul National University Hospital, Seoul, 03808, Korea, Republic of|SoonChunHyang University Seoul Hospital, Seoul, 04401, Korea, Republic of|The Chatholic University of Korea, Yeouido St. Mary's Hospital, Seoul, 07345, Korea, Republic of|Korea University Guro Hospital, Seoul, 08308, Korea, Republic of|Ulsan University Hospital, Ulsan, 44033, Korea, Republic of|Yonsei University Wonju Severance Christian Hospital, Wonju, 26426, Korea, Republic of
URL: https://clinicaltrials.gov/show/NCT06287073