Results from a post-marketing surveillance study investigating Jardiance (empagliflozin) in Korean patients with chronic kidney disease (CKD) were posted on 2026-06-23. The study reported that 46 participants experienced adverse events, with 6 serious adverse events. Efficacy monitoring also showed a significant change in urine albumin-creatinine ratio (UACR) at 12 weeks compared to baseline (p=0.0033).
Background
Jardiance (empagliflozin) is an intervention used in the treatment of chronic kidney disease. This post-marketing surveillance aimed to gather real-world data on its use in a specific patient population.
Trial design
This was a post-marketing surveillance study (NCT06287073) that enrolled 299 participants. The study focused on Korean patients with chronic kidney disease (CKD) receiving Jardiance. The primary objective was to monitor the safety profile of Jardiance in routine clinical practice, while a secondary objective was to monitor efficacy by evaluating changes in urine albumin-creatinine ratio (UACR) after 12 and/or 24 weeks of treatment.
Key results
The study reported the following key measurements for Jardiance treated patients:
- A total of 46 participants experienced adverse events (AEs).
- 6 participants experienced serious adverse events (SAEs).
- 42 participants experienced non-serious adverse events.
- 10 participants experienced adverse drug reactions (ADRs).
- No participants (0) experienced serious adverse drug reactions.
- 15 participants experienced unexpected adverse events.
- No participants (0) experienced adverse events of special interest (AESIs).
- 2 participants experienced specific adverse events.
- 7 participants experienced adverse events leading to temporary or permanent discontinuation.
- Regarding adverse events by intensity, 32 participants and 13 participants were reported in different intensity categories.
Efficacy monitoring included changes in urine albumin-creatinine ratio (UACR):
- A paired t-test comparing week 12 UACR values against baseline showed a p-value of 0.0033.
- A paired t-test comparing week 24 UACR values against baseline showed a p-value of 0.4276.
What this means
The post-marketing surveillance data provides real-world insights into the safety profile of Jardiance in Korean patients with chronic kidney disease. The occurrence of 46 adverse events and 6 serious adverse events indicates that monitoring remains important in clinical practice. Notably, zero serious adverse drug reactions were reported. The statistically significant change in urine albumin-creatinine ratio (UACR) at 12 weeks (p=0.0033) suggests a potential early impact on a key marker of kidney function, aligning with the drug's known benefits in CKD. However, the lack of a significant change at 24 weeks (p=0.4276) warrants further investigation into the long-term patterns of UACR response in this population.
Source
The results of this post-marketing surveillance study were posted on 2026-06-23 on ClinicalTrials.gov, an official database of clinical studies. The full details are available on clinicaltrials.gov under the identifier NCT06287073.