Minimizing Glucocorticoid Administration in Patients With Proliferative Lupus Nephritis

PHASE4RecruitingINTERVENTIONAL
Enrollment

30

Participants

Timeline

Start Date

March 2, 2022

Primary Completion Date

December 31, 2028

Study Completion Date

December 31, 2028

Conditions
Lupus Nephritis
Interventions
DRUG

Rituximab

2 doses of Rituximab 1 g and Methylprednisolone 500 mg on days 1 and 15.

DRUG

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.

DRUG

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.

DRUG

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.

Trial Locations (1)

022328

RECRUITING

Fundeni Clinical Institute, Bucharest

All Listed Sponsors
lead

Institutul Clinic Fundeni

OTHER