Kidney Disease, Chronic
Conditions
Brief summary
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.
Interventions
DRUGJARDIANCE®
JARDIANCE®
Sponsors
Boehringer Ingelheim
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age ≧19 years at enrolment * Patients diagnosed with CKD * Patients with CKD starting JARDIANCE® for the first time in accordance with the approved label in Korea * Patients who have provided informed consent and signed the data release consent form
Exclusion criteria
* Patients with previous exposure to JARDIANCE® * Patients with hypersensitivity to empagliflozin or to any of the excipients * Patients with type 1 diabetes * Patients with history of Diabetic Ketoacidosis (DKA) * Patients with rare hereditary conditions of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption * Patients who are pregnant or are breastfeeding or who plan to become pregnant during the study period
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Adverse Events (AEs) | Up to 337 days. | Number of participants with adverse events (AEs). |
| Number of Participants With Serious Adverse Event (SAEs) | Up to 337 days. | Number of participants with serious adverse event (SAEs). |
| Number of Participants With Non-serious Adverse Events | Up to 337 days. | Number of participants with non-serious adverse events. |
| Number of Participants With Adverse Drug Reaction (ADR)s | Up to 337 days. | Number of participants with adverse drug reaction (ADR)s. |
| Number of Participants With Serious Adverse Drug Reactions | Up to 337 days. | Number of participants with serious adverse drug reactions. |
| Number of Participants With Unexpected Adverse Events | Up to 337 days. | Number of participants with unexpected adverse events. |
| Number of Participants With Adverse Events of Special Interest (AESIs) | Up to 337 days. | Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation. |
| Number of Participants With Specific Adverse Events | Up to 337 days. | Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia. |
| Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation | Up to 337 days. | Number of participants with adverse events leading to temporary or permanent discontinuation. |
| Number of Participants With Adverse Events by Intensity | Up to 337 days. | Number of participants with adverse events by intensity. |
| Number of Participants With Adverse Events by Outcome of the Events | Up to 337 days. | Number of participants with adverse events by outcome of the events. |
| Number of Participants With Adverse Events by Causality | Up to 337 days. | Number of participants with adverse events by causality. |
| Number of Participants With Adverse Events Leading to Death | Up to 337 days. | Number of participants with adverse events leading to death. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment | Data collected at baseline (visit 1), week 12 and week 24. | 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) |
Countries
South Korea
Participant flow
Recruitment details
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.
Pre-assignment details
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.
Baseline characteristics
| Characteristic | — |
|---|---|
| Age, Continuous | 56.3 years STANDARD_DEVIATION 15.72 |
| Sex: Female, Male Female | 100 Participants |
| Sex: Female, Male Male | 173 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 273 |
| other Total, other adverse events | 0 / 273 |
| serious Total, serious adverse events | 6 / 273 |
Outcome results
None listed