Kidney Disease, Chronic
Conditions
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.
Interventions
DRUGJARDIANCE®
JARDIANCE®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of Adverse Drug Reactions (ADRs) | Up to 52 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 cardiovascular death | Up to 52 weeks | — |
| Incidence of all cause death | Up to 52 weeks | — |
| Incidence of hospitalization for heart failure | 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) | — |
Countries
Japan
Outcome results
None listed