A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy
This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).
- Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening
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Screening urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection after best supportive care for >= 3 months prior to screening or screening UPCR >= 4 g/g after best supportive care for >= 6 months prior to screening
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eGFR >= 40 mL/min/1.73m^2 or qualified endogenous creatinine clearance >= 40 mL/min/1.73m^2 based on 24-hour urine collection during screening
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Other inclusion criteria may apply
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Please contact study team for additional inclusion criteria
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- Participants with a secondary cause of MN
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Pregnancy or breastfeeding
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Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization
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Severe renal impairment, including the need for dialysis or renal replacement therapy
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Type 1 or 2 diabetes mellitus
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Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening
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- or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening
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Please contact study team for additional exclusion criteria
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Glomerulonephritis, Membranous
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