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

Fudan University

Status and phase: Enrolling; Phase 3

Conditions: Primary Membranous Nephropathy

Treatments: Drug: CTX combined with Glucocorticoids; Drug: Obinutuzumab

Study type: Interventional

Funder types: Other

Identifiers

NCT06781944

ML45515

Details and patient eligibility

About

This is a randomized, parallel group, active-controlled, open-label, Phase III study comparing the efficacy and safety of obinutuzumab versus cyclophosphamide combined with glucocorticoids in patients with primary membranous nephropathy (pMN). Approximately 144 patients with pMN who have been diagnosed by biopsy or serum anti-PLA2R antibody will be enrolled.

Intervention: Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26 Comparator: 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 40 mg/d) for 27 days.

Oral cyclophosphamide will be given for 30 days in month 2, 4, 6.

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Aged 18～75 years (including 18 and 75)old at the time of signing Informed Consent Form
• pMN patients diagnosed according to renal biopsy (original biopsy needs to include light, immunofluorescence, and electron microscopy) within 5 years or serum anti-PLA2R antibody (≥14 RU/ml )
• 24-hour UPCR ≥ 4 g/g and serum albumin (sALB) < 30 g/L,despite being treated with ACEi and/or ARB for ≥ 6 months prior to screening, or 24-hour UPCR ≥ 5 g/g and sALB < 30 g/L , despite being treated with ACEi and/or ARB for ≥ 3 months prior to screening; or 24-hour UPCR ≥ 8 g/g and sALB < 25 g/L, despite being treated with ACEi and/or ARB for ≥ 1 month prior to screening,.
• eGFR ≥40 mL/min/1.73m2 (CKD-EPI), a renal biopsy is required to exclude renal damage due to other co-morbidities if eGFR <60mL/min/1.73 m2.
• Ability to comply with the study protocol, in the investigator's judgment

Exclusion criteria

• Patients with a secondary cause of MN (e.g. hepatitis B, systemic lupus erythematosus, medications, malignancies)
• Type 1 or 2 diabetes mellitus
• eGFR <40 mL/min/1.73m2 (CKD-EPI) or dialysis or kidney transplantation
• Evidence of 50% reduction in proteinuria or serum anti-PLA2R antibody within 6 months prior to screening

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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144 participants in 2 patient groups

Obinutuzumab

Experimental group

Description:

Intravenous infusion of 1,000 mg obinutuzumab at weeks 0, 2, 24 and 26.

Treatment:

Drug: Obinutuzumab

Comparator

Other group

Description:

Comparator

Treatment:

Drug: CTX combined with Glucocorticoids