Overview

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