OBINOTUZUMAB Versus Cyclophosphamide + Glucocorticoids in Primary Membranous Nephropathy(Blossom Study)

PHASE3RecruitingINTERVENTIONAL
Enrollment

144

Participants

Timeline

Start Date

October 23, 2024

Primary Completion Date

May 31, 2028

Study Completion Date

May 31, 2028

Conditions
Primary Membranous Nephropathy
Interventions
DRUG

Cyclophosphamide (CTX)

"Participants in the control arm will receive cyclical cyclophosphamide and glucocorticoids.~Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.~The dosage is adjusted based on the age and renal function (rounded down to the nearest 25 mg, max 100 mg/day, Cyclophosphamide tablets should not be split; if necessary, alternating doses of 50 mg/day and 100 mg/day can be used):~* 2.0 mg/kg/d in patients \< 65 years with eGFR ≥60ml/min~* 1.5 mg/kg/d in patients \< 65 years with eGFR\<60ml/min~* 1.5 mg/kg/d in patients ≥ 65 years with eGFR ≥60ml/min~* 1.0 mg/kg/d in patients ≥ 65 years with eGFR\<60ml/min"

DRUG

Glucocorticoids

"Participants in the control arm will receive cyclical cyclophosphamide and glucocorticoids.~Methylprednisolone 500 mg iv will be given for 3 consecutive days at the start of month 1,3,5 and followed by prednisone 0.5mg/kg/d (max 40mg/d) for 27 days."

Trial Locations (1)

200040

RECRUITING

Huashan Hospital, Fudan University, Shanghai

All Listed Sponsors
lead

Huashan Hospital

OTHER