A randomized controlled trial of Dapagliflozin added to standard of care in proliferative lupus nephritis: Assessment of renal and immunological outcomes

Systemic lupus erythematosus (SLE) is a chronic autoimmune disease in which renal involvement in the form of Lupus Nephritis contributes significantly to morbidity and mortality. Current standard treatments include corticosteroids and immunosuppressants, but a proportion of patients fail to achieve adequate renal response, and long-term toxicity due to corticosteroid use remains a major concern. Sodium-glucose cotransporter-2 (SGLT2) inhibitors such as Dapagliflozin have shown kidney-protective effects in diabetes and chronic kidney disease, but data in lupus nephritis are limited.

This study is a randomized, double-blind, placebo-controlled trial evaluating the addition of Dapagliflozin to standard of care in patients with proliferative lupus nephritis. 84 patients who are more than or equal to 18 years old with biopsy-proven proliferative lupus nephritis (class III/IV/III+V/IV+V) will be enrolled and randomized in a 1:1 ratio to receive Dapagliflozin 10 mg once daily plus standard of care, or placebo plus standard of care.

The primary objective is to compare the rate of complete renal response at 6 months between the two groups as per KDIGO 2024 criteria. Secondary objectives include assessing partial renal response in both groups at 6 months, renal response including partial and complete remission in the study group at 12 months, rates of lupus flares at 1 year, adverse events, and immunological changes in peripheral blood cell subsets at beginning and at the end of 6 months after intervention.

The study duration will be 18 months including recruitment and follow-up. This trial aims to provide important data on the safety and efficacy of Dapagliflozin as an adjunct therapy in proliferative lupus nephritis.