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

Authors
Category Primary study
Registry of TrialsBrazilian Registry of Clinical Trials
Year 2023
INTERVENTION: 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. The design will be carried out with half of the group receiving dapagliflozin 10mg, on top of standard care, and the other half not receiving dapagliflozin for 24 weeks. After this period, we will do a 4‐week washout, and participants who received dapagliflozin will not receive the drug and vice versa. CONDITION: Lupus Nephritis M32‐1 PRIMARY OUTCOME: 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 OUTCOME: 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 the behavior of systolic and diastolic blood pressure, after si Xmonths 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. 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. ; Evaluate whether there is a reduction in body weight after si Xmonths 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. ; 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
Epistemonikos ID: 488d90d60241be87983a97784402411d507d1f39
First added on: Feb 20, 2024