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

Running, not enrolling · Phase 3

Conditions studied: Primary Membranous Nephropathy

In brief

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

Key facts

Study ID

NCT04629248

Run by

Hoffmann-La Roche

People needed

142

Starts

2021-06-25

Expected to finish

2027-12-21

Last updated by the study team

2026-07-07

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Kaiser Permanente - San Francisco Medical Center — San Francisco, California, United States
• University of Colorado in Denver-Anschutz Medical Campus — Aurora, Colorado, United States
• Accel Research Sites; Mid-Florida Kidney and Hypertension Care — Altamonte Springs, Florida, United States
• University of Iowa — Iowa City, Iowa, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• Mayo Clinic — Rochester, Minnesota, United States
• Columbia University Medical Center — New York, New York, United States
• Nephrotex Research Group — Dallas, Texas, United States
• Organizacion Medica de Investigacion — Buenos Aires, Argentina
• CINME — Buenos Aires, Argentina
• Hospital Britanico Buenos Aires — Buenos Aires, Argentina
• Ser Servicos Especializados Em Reumatologia — Salvador, Estado de Bahia, Brazil
• Hospital de Base de Sao Jose do Rio Preto — São José do Rio Preto, São Paulo, Brazil
• Hospital do Rim e Hipertensão - Fundação Oswaldo Ramos — São Paulo, São Paulo, Brazil
• Hospital das Clinicas - FMUSP — São Paulo, São Paulo, Brazil
• Zhejiang Provincial People?s Hospital — Hangzhou, Zhejiang, China
• Peking University First Hospital — Beijing, China
• Sichuan Provincial People's Hospital — Chengdu, China
• The 1st Affiliated hospital of Fujian Medical University — Fuzhou, China
• Nanfang Hospital, Southern Medical University — Guangzhou, China
• Ruijin Hospital, Shanghai Jiaotong University School of Medicine — Shanghai, China
• Huashan Hospital, Fudan University — Shanghai, China
• Tongji Hospital Tongji Medical College Huazhong University of Science and Technology — Wuhan, China
• The First Affiliated Hospital of Xian Jiao Tong University — Xi'an, China
• General Hospital of Ningxia Medical University — Yinchuan, China

Full record on ClinicalTrials.gov

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