The use of Dapagliflozin in patients with Kidney Disease due to Systemic Lupus Erythematosus

Phase 3

Recruiting

• Conditions: upus Nephritis; M32-1

• Registration Number: RBR-3vcg568
• Lead Sponsor: Hospital das Clínicas/Empresa Brasileira de Serviços Hospitalares/Universidade Federal de Pernambuco

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2023-03-06
• Last Update Posted: 29 May 2023
• Study Completion: 2024-10-01

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: Not specified

Inclusion Criteria

Adults; both genders; patients with class III, IV and/or V inactive Lupus Nephritis with proteinuria >500mg/24h and/or urine abumin/creatinine ratio > 200mg/g and estimated glomerular filtration rate > 20ml/min; use of stable maintenance immunosuppression > 4 weeks

Exclusion Criteria

Active lupus nephritis (activity index >2 on biopsy less than 12 months old); induction treatment with Cyclophosphamide, Mycophenolate Mofetil >2g/day or associated Cyclosporine regimen; patients with a history of recurrent urinary tract infection (more than 3 episodes per year); clinical or laboratory suspicion of renal or extra-renal lupus activity requiring increased immunosuppression in the last 6 months; use of prednisone at doses greater than 20mg/day for more than 15 days; patients with type 1 or 2 diabetes with Diabetic Nephropathy on renal biopsy; patients with chronic kidney disease of another etiology

Study & Design

• Study Type: Intervention
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Evaluate the percentage change in proteinuria, measured by 24-hour proteinuria and/or urine albumin/creatinine ratio at the end of each six-month period; it is expected to find a significant reduction of 25% in relation to the baseline.