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| ID | Type | Description | Link |
|---|---|---|---|
| EUPAS107293 | Registry Identifier | EU PAS Register |
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The primary objective is to monitor the safety profile of JARDIANCE® in Korean patient with chronic kidney disease (CKD) in routine clinical practice.
The secondary objective is to monitor the efficacy of JARDIANCE® by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| JARDIANCE® treated patients | Patients with chronic kidney disease (CKD) who started JARDIANCE® for the first time in accordance with the approved label in Korea, treated according to routine clinical practice. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| JARDIANCE® | Drug | JARDIANCE® |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Number of participants with adverse events (AEs). | Up to 337 days. |
| Number of Participants With Serious Adverse Event (SAEs) | Number of participants with serious adverse event (SAEs). | Up to 337 days. |
| Number of Participants With Non-serious Adverse Events | Number of participants with non-serious adverse events. | Up to 337 days. |
| Number of Participants With Adverse Drug Reaction (ADR)s | Number of participants with adverse drug reaction (ADR)s. | Up to 337 days. |
| Number of Participants With Serious Adverse Drug Reactions | Number of participants with serious adverse drug reactions. | Up to 337 days. |
| Number of Participants With Unexpected Adverse Events | Number of participants with unexpected adverse events. | Up to 337 days. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation. | Up to 337 days. |
| Number of Participants With Specific Adverse Events |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment | Change in Urine Albumin-Creatinine Ratio (UACR) from baseline after 12 weeks and 24 weeks of treatment. UACR is calculated as albumin (milligrams)/creatinine (grams) | Data collected at baseline (visit 1), week 12 and week 24. |
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Inclusion Criteria:
Exclusion Criteria:
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This is a single-arm, open-label, multi-centre observational and non-interventional study (ONIS) based on newly collected data. This study will be carried out by enrolling patients in a consecutive manner into the study requiring completion of case report forms (CRFs) for all participants who initially administered JARDIANCE® following the study start date until the planned number of participants is reached.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hallym University Sacred Heart Hospital | Anyang | 07441 | South Korea | |||
| Chungbuk National University Hospital |
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| Label | URL |
|---|---|
| Related Info | View source |
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Once the criteria in section 'time frame frame' are fulfilled , researchers can use the following link https://www.mystudywindow.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.
All subjects were screened for eligibility prior to participation in the trial. Subjects were not to be allocated to a treatment group if any of the entry criteria were violated. Out of the 299 enrolled subjects, 26 subjects were not included in the safety set.
This was a single-arm, open-label, multicenter, observational, non-interventional study to monitor the safety profile and efficacy of JARDIANCE® in Korean patients with CKD in routine clinical practice.
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| ID | Title | Description |
|---|---|---|
| FG000 | JARDIANCE® Treated Patients | Patients with chronic kidney disease (CKD) who started JARDIANCE® for the first time in accordance with the approved label in Korea, treated according to routine clinical practice. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 28, 2024 | Apr 13, 2026 |
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Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia. |
| Up to 337 days. |
| Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation | Number of participants with adverse events leading to temporary or permanent discontinuation. | Up to 337 days. |
| Number of Participants With Adverse Events by Intensity | Number of participants with adverse events by intensity. | Up to 337 days. |
| Number of Participants With Adverse Events by Outcome of the Events | Number of participants with adverse events by outcome of the events. | Up to 337 days. |
| Number of Participants With Adverse Events by Causality | Number of participants with adverse events by causality. | Up to 337 days. |
| Number of Participants With Adverse Events Leading to Death | Number of participants with adverse events leading to death. | Up to 337 days. |
| Cheongiu |
| 28644 |
| South Korea |
| Yonsei University Wonju Severance Christian Hospital | Gangwon | 26426 | South Korea |
| Inje University Ilsan Paik Hospital | Goyang | 10380 | South Korea |
| Chonnam National University Hospital | Gwangju | 61469 | South Korea |
| Korea University Anam Hospital | Seoul | 02841 | South Korea |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| The Catholic University of Korea, Eunpyeong St. Mary's Hospital | Seoul | 03312 | South Korea |
| Soonchunhyang University Hospital Seoul | Seoul | 04401 | South Korea |
| Samsung Medical Center | Seoul | 06351 | South Korea |
| The Catholic University of Korea, Yeouido St.Mary's Hospital | Seoul | 07345 | South Korea |
| Ulsan University Hospital | Ulsan | 44033 | South Korea |
| COMPLETED |
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| NOT COMPLETED |
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The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more.
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| ID | Title | Description |
|---|---|---|
| BG000 | JARDIANCE® Treated Patients | Patients with chronic kidney disease (CKD) who started JARDIANCE® for the first time in accordance with the approved label in Korea, treated according to routine clinical practice. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Events (AEs) | Number of participants with adverse events (AEs). | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
|
| ||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Event (SAEs) | Number of participants with serious adverse event (SAEs). | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Non-serious Adverse Events | Number of participants with non-serious adverse events. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Drug Reaction (ADR)s | Number of participants with adverse drug reaction (ADR)s. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Serious Adverse Drug Reactions | Number of participants with serious adverse drug reactions. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
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| |||||||||||||||||||||||||||
| Primary | Number of Participants With Unexpected Adverse Events | Number of participants with unexpected adverse events. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events of Special Interest (AESIs) | Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Specific Adverse Events | Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation | Number of participants with adverse events leading to temporary or permanent discontinuation. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events by Intensity | Number of participants with adverse events by intensity. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. A single patient can appear in multiple categories. | Posted | Count of Participants | Participants | Up to 337 days. |
|
| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events by Outcome of the Events | Number of participants with adverse events by outcome of the events. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. A single patient can appear in multiple categories. | Posted | Count of Participants | Participants | Up to 337 days. |
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| |||||||||||||||||||||||||||
| Primary | Number of Participants With Adverse Events by Causality | Number of participants with adverse events by causality. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. A single patient can appear in multiple categories. | Posted | Count of Participants | Participants | Up to 337 days. |
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| Primary | Number of Participants With Adverse Events Leading to Death | Number of participants with adverse events leading to death. | The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more. | Posted | Count of Participants | Participants | Up to 337 days. |
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| Secondary | Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment | Change in Urine Albumin-Creatinine Ratio (UACR) from baseline after 12 weeks and 24 weeks of treatment. UACR is calculated as albumin (milligrams)/creatinine (grams) | The efficacy set included those who signed the data release consent form to participate in this study, had at least one follow-up visit, took JARDIANCE®, and had at least some follow-up data for the efficacy. Patients for whom UACR results were not collected at baseline or post-baseline were excluded. | Posted | Mean | Standard Deviation | Milligrams/grams | Data collected at baseline (visit 1), week 12 and week 24. |
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Up to 337 days.
The safety set included all patients who signed the data release consent form to participate in this study, took JARDIANCE® once at least, and were followed up by the physician once or more.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | JARDIANCE® Treated Patients | Patients with chronic kidney disease (CKD) who started JARDIANCE® for the first time in accordance with the approved label in Korea, treated according to routine clinical practice. | 0 | 273 | 6 | 273 | 0 | 273 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Glomerulonephritis chronic | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Nephrolithiasis | Renal and urinary disorders | MedDRA 28.0 | Systematic Assessment |
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| Atrial fibrillation | Cardiac disorders | MedDRA 28.0 | Systematic Assessment |
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| Gastric ulcer haemorrhage | Gastrointestinal disorders | MedDRA 28.0 | Systematic Assessment |
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| Hepatic cyst | Hepatobiliary disorders | MedDRA 28.0 | Systematic Assessment |
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| COVID-19 | Infections and infestations | MedDRA 28.0 | Systematic Assessment |
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| Hyponatraemia | Metabolism and nutrition disorders | MedDRA 28.0 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 23, 2024 | Apr 13, 2026 | SAP_001.pdf |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| 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 |
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| ID | Term |
|---|---|
| C570240 | empagliflozin |
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