Trial results for dapagliflozin in patients with lupus nephritis were posted on ClinicalTrials.gov on 2025-04-16. The study, NCT05748925, investigated the cardio-renal effects of SGLT2 inhibitors. After one year, participants receiving dapagliflozin showed mean renal function values of 128 mL/min/1.73 m² and 115.7 mL/min/1.73 m², compared to 114 mL/min/1.73 m² and 100.3 mL/min/1.73 m² in the placebo group.
Background
Dapagliflozin is a sodium-glucose cotransporter 2 (SGLT2) inhibitor. This class of drugs is known for its effects on glucose reabsorption in the kidneys. The study aimed to assess the role of SGLT2 inhibitors in the regression of ongoing kidney and cardiac diseases among lupus nephritis patients, including both diabetic and non-diabetic individuals, under various immunosuppressive therapies.
Trial design
The study (NCT05748925), titled 'Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients,' was a Phase 4 trial that enrolled 84 participants. The trial investigated the effects of dapagliflozin compared to placebo in patients with SLE and Lupus Nephritis. The main objective was to compare the use of SGLT2 inhibitors versus standard care in the regression of chronic kidney disease in patients with lupus nephritis.
Key results
The trial reported several key measurements after one year.
For the outcome 'Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year':
- In the dapagliflozin group, mean renal function was measured at 128 mL/min/1.73 m² (Standard Deviation: 59.7) and also at 115.7 mL/min/1.73 m² (Standard Deviation: 48).
- In the placebo group, mean renal function was measured at 114 mL/min/1.73 m² (Standard Deviation: 51) and also at 100.3 mL/min/1.73 m² (Standard Deviation: 44.5).
For 'Cardiovascular Assessment in Two Groups':
- The dapagliflozin group had 11 Participants and 11 Participants reported for this outcome.
- The placebo group had 3 Participants and 1 Participant reported for this outcome.
For 'Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level':
- In the dapagliflozin group, mean erythropoietin level was 11.3 international units per liter (IU/L) (Standard Deviation: 1.4) and 12.4 international units per liter (IU/L) (Standard Deviation: 3.5).
- In the placebo group, mean erythropoietin level was 11.6 international units per liter (IU/L) (Standard Deviation: 2.1) and 12.8 international units per liter (IU/L) (Standard Deviation: 3.5).
What this means
The results from this Phase 4 trial suggest that dapagliflozin may be associated with higher mean renal function values compared to placebo in patients with lupus nephritis after one year. While the data shows numerical differences in renal function, the absence of statistical analyses such as p-values or confidence intervals in the posted results means that definitive conclusions about statistical significance cannot be drawn from this information alone. Further analysis would be needed to fully understand the clinical implications of these findings for managing chronic kidney disease in lupus nephritis patients.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for study NCT05748925, titled 'Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients,' were posted on 2025-04-16 on clinicaltrials.gov.