Minimizing Glucocorticoid administration in patients with Proliferative Lupus Nephritis (GLUREDLUP)
ClinicalTrials.gov #NCT05207358
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.
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
