| Trial ID: | L0132 |
| Source ID: | NCT06527846
|
| Associated Drug: |
Jardiance®
|
| Title: |
Post Marketing Surveillance of JARDIANCE in Chronic Kidney Disease
|
| Acronym: |
|
| Status: |
RECRUITING
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Kidney Disease, Chronic
|
| Interventions: |
DRUG: JARDIANCE®
|
| Outcome Measures: |
Primary: Incidence of Adverse Drug Reactions (ADRs), Up to 52 weeks | Secondary: Kidney disease progression, 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., Up to 52 weeks|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)
|
| Sponsor/Collaborators: |
Sponsor: Boehringer Ingelheim
|
| Gender: |
ALL
|
| Age: |
CHILD, ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
1000
|
| Study Type: |
OBSERVATIONAL
|
| Study Designs: |
Observational Model: |Time Perspective: p
|
| Start Date: |
2024-10-22
|
| Completion Date: |
2027-05-31
|
| Results First Posted: |
|
| Last Update Posted: |
2024-11-22
|
| Locations: |
Nippon Boehringer Ingelheim Co., Ltd., Tokyo, 1416017, Japan
|
| URL: |
https://clinicaltrials.gov/show/NCT06527846
|
