Lupus Nephritis
Conditions
Interventions
The phase 2 clinical trial will be open, cross-over, randomized and controlled using dapagliflozin in patients without active lupus nephritis. We will recruit 32 patients with inactive Lupus Nephritis
Sponsors
Hospital das Clínicas/Empresa Brasileira de Serviços Hospitalares/Universidade Federal de Pernambuco
Hospital das Clínicas/Empresa Brasileira de Serviços Hospitalares/Universidade Federal de Pernambuco
Eligibility
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate whether therapy with Dapagliflozin leads to an increase in the number of infections; we do not expect to find a difference in relation to the period without the use of the drug. ;Assess if the estimated sustained glomerular filtration rate worsens; measured by the CDK-EPI 2021 equation compared to the baseline, being considered significant if it is 30% lower than the baseline on two different occasions; we do not expect to find a difference in relation to the baseline. ;Evaluate whether there is a reduction in body weight after six months of treatment with Dapagliflozin compared to the period without the drug; a reduction of 1-3 kg is expected with drug use in relation to the period without drug use. ;Evaluate the behavior of systolic and diastolic blood pressure, after six months of treatment with Dapagliflozin or isolated standard therapy, in relation to the average of initial dosages (time 0); a reduction of 2-5mmHg in mean systolic and diastolic blood pressure is expected with the use of the medication in relation to the baseline. | — |
Countries
Brazil
Contacts
Public ContactGisele Fernandes
Universidade Federal de Pernambuco - Hospital das Clínicas
Outcome results
None listed