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

Roche

Status and phase: Active, not recruiting; Phase 3

Conditions: Primary Membranous Nephropathy

Treatments: Drug: Tacrolimus; Drug: Methylprednisolone; Drug: Obinutuzumab; Drug: Acetaminophen; Drug: Diphenhydramine

Study type: Interventional

Funder types: Industry

Identifiers

NCT04629248

2020-003233-38 (EudraCT Number)

2023-506525-11-00 (Other Identifier)

WA41937

Details and patient eligibility

About

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

Enrollment: 140 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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140 participants in 2 patient groups

Open Label Treatment: Obinutuzumab

Experimental group

Description:

Participants will be randomized at a 1:1 ratio to receive open-label treatment with obinutuzumab according to region and anti-phospholipase A2 receptor (PLA2R) autoantibody titer (using Euroimmun ELISA).

Treatment:

Drug: Diphenhydramine

Drug: Acetaminophen

Drug: Obinutuzumab

Drug: Methylprednisolone

Open Label Treatment: Tacrolimus

Active Comparator group

Description:

Participants will be randomized at a 1:1 ratio to receive open-label treatment with tacrolimus according to region and anti-PLA2R autoantibody titer (using Euroimmun ELISA).

Treatment:

Drug: Tacrolimus