Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
- Registration Number
- NCT06527846
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
Study objective is to investigate the safety and effectiveness of long-term daily use of JARDIANCE® Tablets in patients with chronic kidney disease under real-world use.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 1000
Inclusion Criteria
- Patients with CKD who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and who provided written informed consent prior to enrolment in this study.
- Patients who have never been treated with JARDIANCE® Tablets (including treatment for Type 2 diabetes mellitus (T2DM) and/or chronic heart failure (CHF)) before enrolment.
Exclusion Criteria
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with chronic kidney disease (CKD) JARDIANCE® -
- Primary Outcome Measures
Name Time Method Incidence of Adverse Drug Reactions (ADRs) Up to 52 weeks
- Secondary Outcome Measures
Name Time Method Kidney disease progression Up to 52 weeks Kidney disease progression defined as incidence of end stage kidney disease (ESKD), a sustained decline in estimated glomerular filtration rate (eGFR) to \<10 mL/min/1.73 m\^2, renal death, or a sustained decline of ≥40% in eGFR from baseline).
ESKD is defined as the initiation of maintenance dialysis or receipt of a kidney transplant.Incidence of hospitalization for heart failure Up to 52 weeks Incidence of cardiovascular death Up to 52 weeks Incidence of all cause death Up to 52 weeks Change from baseline in eGFR to the last observation on treatment at baseline, at last observation on treatment (Up to 52 weeks)
Trial Locations
- Locations (1)
Nippon Boehringer Ingelheim Co., Ltd.
🇯🇵Tokyo, Japan