Minimizing Glucocorticoid administration in patients with Proliferative Lupus Nephritis (GLUREDLUP)
The aim of the study is to evaluate the efficacy of a therapeutic regimen which decreases glucocorticoid exposure compared with standard therapy in patients with proliferative lupus nephritis during remission induction by evaluating the histological and clinical remission.
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How is this study performed?
This is a randomized controlled trial where after an initial screening phase during which a first kidney biopsy is performed, all patients that meet the inclusion criteria will be randomized to one of the treatment arms:
EURO LUPUS regimen: 3 daily pulses of 750 mg of intravenous Methylprednisolone, followed by oral corticosteroid therapy starting with a dose of 0.5 mg / kg / day for 4 weeks, then decreased by 2.5 mg of Prednisolone / day each 2 weeks and a maintenance steroid of 5-7.5 mg / day. All patients will receive Cyclophosphamide followed by Azathioprine.
RITUXILUP regimen: 2 doses of Rituximab 1 g and Methylprednisolone 500 mg on days 1 and 15. Patients will receive Mycophenolate Mofetil, initially 500 mg twice daily, titrated to a maximum of 1.5 g twice daily maintained for 24 months.
A second kidney biopsy will be performed 6 months after the start of the treatment phase.
The primary outcome is the percentage of participants with a histological remission
Eligibility Criteria
Aged between18 and 80 years,
Diagnosis of proliferative lupus nephritis class III, IV +/- V (confirmed by renal biopsy and classified according to ISN / RPS);
Estimated glomerular filtration rate by CKD-EPI> 30 ml / min / 1.73 sqm
Estimated glomerular filtration rate by CKD-EPI <30 ml / min / 1.73 sqm but> 15 ml / min / 1.73 sqm with chronicity index (according to NIH score) <6