Trial Outcomes & Findings for JARDIANCE® Post Marketing Surveillance in Korean Patients With Chronic Kidney Disease (CKD) (NCT NCT06287073)
NCT ID: NCT06287073
Last Updated: 2026-06-23
Results Overview
Number of participants with adverse events leading to death.
COMPLETED
299 participants
Up to 337 days.
2026-06-23
Participant Flow
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.
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.
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
273
|
|
Overall Study
COMPLETED
|
273
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 15.72 • n=273 Participants
|
|
Sex: Female, Male
Female
|
100 Participants
n=273 Participants
|
|
Sex: Female, Male
Male
|
173 Participants
n=273 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse events (AEs).
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events (AEs)
|
46 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with serious adverse event (SAEs).
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Serious Adverse Event (SAEs)
|
6 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with non-serious adverse events.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Non-serious Adverse Events
|
42 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse drug reaction (ADR)s.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Drug Reaction (ADR)s
|
10 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with serious adverse drug reactions.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Serious Adverse Drug Reactions
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with unexpected adverse events.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Unexpected Adverse Events
|
15 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Adverse events of special interest (AESIs) consist of: Liver injury, Ketoacidosis in diabetic and nondiabetic population, Lower limb amputation.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events of Special Interest (AESIs)
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Specific adverse events consist of: Severe hypoglycaemia, Urinary tract infection, Genital infection, Bone fracture, Urinary tract malignancy, Volume depletion, Acute kidney injury, Gout, Hyperkalaemia.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Specific Adverse Events
|
2 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse events leading to temporary or permanent discontinuation.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation
Temporary discontinuation
|
0 Participants
|
|
Number of Participants With Adverse Events Leading to Temporary or Permanent Discontinuation
Permanent discontinuation
|
7 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse events by intensity.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events by Intensity
Mild Intensity
|
32 Participants
|
|
Number of Participants With Adverse Events by Intensity
Moderate Intensity
|
13 Participants
|
|
Number of Participants With Adverse Events by Intensity
Severe Intensity
|
3 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse events by outcome of the events.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events by Outcome of the Events
Recovered
|
39 Participants
|
|
Number of Participants With Adverse Events by Outcome of the Events
Not yet recovered
|
8 Participants
|
|
Number of Participants With Adverse Events by Outcome of the Events
Recovered with sequelae
|
0 Participants
|
|
Number of Participants With Adverse Events by Outcome of the Events
Fatal
|
0 Participants
|
|
Number of Participants With Adverse Events by Outcome of the Events
Unknown
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse events by causality.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events by Causality
Probable/Likely
|
5 Participants
|
|
Number of Participants With Adverse Events by Causality
Possible
|
4 Participants
|
|
Number of Participants With Adverse Events by Causality
Conditional/Unclassified
|
0 Participants
|
|
Number of Participants With Adverse Events by Causality
Unassessable/Unclassifiable
|
0 Participants
|
|
Number of Participants With Adverse Events by Causality
Unlikely
|
37 Participants
|
|
Number of Participants With Adverse Events by Causality
Certain
|
1 Participants
|
PRIMARY outcome
Timeframe: Up to 337 days.Population: 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.
Number of participants with adverse events leading to death.
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=273 Participants
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.
|
|---|---|
|
Number of Participants With Adverse Events Leading to Death
|
0 Participants
|
SECONDARY outcome
Timeframe: Data collected at baseline (visit 1), week 12 and week 24.Population: 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.
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)
Outcome measures
| Measure |
JARDIANCE® Treated Patients
n=84 Participants
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.
|
|---|---|
|
Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment
Week 12 - Baseline
|
-163.65 Milligrams/grams
Standard Deviation 474.780
|
|
Change in Urine Albumin-Creatinine Ratio (UACR) From Baseline After 12 Weeks and 24 Weeks of Treatment
Week 24 - Baseline
|
-30.35 Milligrams/grams
Standard Deviation 455.083
|
Adverse Events
JARDIANCE® Treated Patients
Serious adverse events
| Measure |
JARDIANCE® Treated Patients
n=273 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
Glomerulonephritis chronic
|
0.37%
1/273 • 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.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.37%
1/273 • 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.
|
|
Cardiac disorders
Atrial fibrillation
|
0.37%
1/273 • 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.
|
|
Gastrointestinal disorders
Gastric ulcer haemorrhage
|
0.37%
1/273 • 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.
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.37%
1/273 • 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.
|
|
Infections and infestations
COVID-19
|
0.37%
1/273 • 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.
|
|
Metabolism and nutrition disorders
Hyponatraemia
|
0.37%
1/273 • 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.
|
Other adverse events
Adverse event data not reported
Additional Information
Boehringer Ingelheim, Call Center
Boehringer Ingelheim
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place