30
Participants
Start Date
March 2, 2022
Primary Completion Date
December 31, 2028
Study Completion Date
December 31, 2028
Rituximab
2 doses of Rituximab 1 g and Methylprednisolone 500 mg on days 1 and 15.
Mycophenolate Mofetil
Patients will receive Mycophenolate Mofetil, initially 500 mg twice daily, titrated to a maximum of 1.5 g twice daily, depending on leukocyte count and digestive tolerance, which will be maintained 24 months.
Cyclophosphamide
All patients will receive Cyclophosphamide intravenously starting day 1, 6 pulses at a fixed dose of 500 mg given at 2 weeks. After 3 months, Azathioprine (2 mg / kg / day) is initiated 2 weeks after the last administration of Cyclophosphamide and maintained for the next 21 months.
Corticosteroids
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. A low dose of glucocorticoid (5-7.5 mg / day) is maintained until 24 months after enrollment.
RECRUITING
Fundeni Clinical Institute, Bucharest
Institutul Clinic Fundeni
OTHER