1. What data in particular will be shared?
   Response - All of the individual participant data collected during the trial, after de-identification.
   


2. What additional supporting information will be shared?
   Response -  Study Protocol
   Response -  Statistical Analysis Plan
   Response - Informed Consent Form
   Response - Clinical Study Report
   
   
3. Who will be able to view these files?
   Response - Researchers who provide a methodologically sound proposal.
   


4. For what types of analyses will this data be available?
   Response - For individual participant data meta-analysis.
   


5. By what mechanism will data be made available?
   Response (Others) -  Proposals should be directed to rkl.sriya@gmail.com


6. For how long will this data be available start date provided 31-07-2027 and end date provided 31-12-2029?
   Response - Immediately following publication. No end date.
   


7. Any URL or additional information regarding plan/policy for sharing IPD? 
   Additional Information - nil

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, open-label, 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 just 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.