Health Condition 1: M321- Systemic lupus erythematosus withorgan or system involvement
Conditions
Interventions
Intervention1: Dapagliflozin: Dapagliflozin 10 mg OD for 6 months during the Induction Phase of treatment in addition to the standard of care
Control Intervention1: NIL: NIL
Sponsors
AIIMS Rishikesh
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have a clinical classification into Systemic Lupus Erythematosus (SLE) according to the ACR/EULAR 2019 criteria (Annexure-II) 2. Have active, biopsy-proven lupus nephritis Class III/ IV /V or in combination using ISN/RPS 2003 criteria (Annexure-II), newly diagnosed or relapse after achieving CRR 3. The biopsy must be performed within 3 months before the screening visit or during the screening period. 4. Require induction therapy with high-dose corticosteroids with either intravenous (IV) cyclophosphamide (CYC) or MMF
Exclusion criteria
Exclusion criteria: 1.History or symptoms suggestive of recurrent UTI, that is more than 1 episode in 6 months 2.Current Vaginal Candidiasis 3. Stable eGFR of less than 30 mL per min at baseline or requiring RRT 4.Diabetes Mellitus
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the proportion of patients with active LN achieving Partial or Complete Renal Response PRR or CRR at 6 months with Dapagliflozin with Standard of Care versus Standard of Care alone Timepoint: 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion achieving PRR at 3 months 2. Change in eGFR calculated using the CKD-EPI 2021 equation, over 6 months 3. Reduction in proteinuria at 3 and 6 months 4. Impact on cardiometabolic profile that is Pulse Rate, BP, Weight, Lipids, HbA1c, LVEF. 5.Change in clinical SLEDAI at 12 weeks and SLEDAI-2K at 24 weeks 6. Adverse drug reactions hypoglycemia, UTI, DKA, AKI, dehydrationTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactAbhishek Rai
AIIMS Rishikesh
Outcome results
None listed