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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with chronic kidney disease (CKD) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JARDIANCE® | Drug | JARDIANCE® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Adverse Drug Reactions (ADRs) | Up to 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with chronic kidney disease (CKD) who are prescribed JARDIANCE® Tablets for CKD according to the current Japanese package insert and never been treated with JARDIANCE® Tablets before enrolment.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nippon Boehringer Ingelheim Co., Ltd. | Tokyo | 1416017 | Japan |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".
Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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| 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) |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |