A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy

• Status: Recruiting
• Trial end date: 2028-06-01
• Target enrollment: 0
• Participant gender: All

Summary

This study will evaluate the efficacy, safety, pharmacodynamics, and pharmacokinetics (PK) of obinutuzumab compared with tacrolimus in participants with primary membranous nephropathy (pMN).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Acetaminophen; Diphenhydramine; Methylprednisolone; Obinutuzumab; Promethazine; Tacrolimus

Criteria

Inclusion Criteria:

• Diagnosis of primary membranous nephropathy (pMN) according to renal biopsy prior to or during screening

• Urinary protein-to-creatinine ratio (UPCR) >= 5 g/g from 24-hour urine collection despite best supportive care for >= 3 months prior to screening or UPCR >= 4 g/g despite best supportive care >= 6 months prior to screening

• 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

• Other inclusion criteria may apply

Exclusion Criteria:

• Participants with a secondary cause of MN

• Pregnancy or breastfeeding

• Evidence of >= 50% reduction in proteinuria during the previous 6 months prior to randomization

• Severe renal impairment, including the need for dialysis or renal replacement therapy

• Type 1 or 2 diabetes mellitus

• Receipt of an excluded therapy, including any anti-CD20 therapy less than 9 months prior to or during screening; or cyclophosphamide, tacrolimus, or cyclosporin less than 6 months prior to or during screening

• Significant or uncontrolled medical disease which, in the investigator's opinion, would preclude participant participation

• Known active infection of any kind or recent major episode of infection

• Major surgery requiring hospitalization within the 4 weeks prior to screening

• Current active alcohol or drug abuse or history of alcohol or drug abuse within 12 months prior to screening

• Intolerance or contraindication to study therapies

• Other exclusion criteria may apply