🏛️ Verified NIH Record • Updated 2026-07-03

A Study Evaluating the Efficacy and Safety of Obinutuzumab in Participants With Primary Membranous Nephropathy (NCT04629248)

A Phase III Randomized, Open-Label Active Comparator-Controlled Multicenter Study to Evaluate Efficacy and Safety of Obinutuzumab in Patients With Primary Membranous Nephropathy

🔵 Active, Not Recruiting Phase3 💊 Investigational Drug / Biologic Sponsor: Hoffmann-La Roche

🩺 Plain-English Summary (8th-Grade Level)

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

Who can join: To join this study, participants generally need to meet the listed inclusion criteria (4 items) and avoid the listed exclusions (13 items).

Location: Kaiser Permanente - San Francisco Medical Center — San Francisco, California

Age range: 18 Years to 75 Years

🧪 Interventions in This Study

📋 "Do I Qualify?" — 1-Minute Self Screener

Instant Checklist

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

Usually NOT eligible if any of the following 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

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (50 Sites)

Showing the first 25 of 50 sites.

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

💰 Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA § 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

More studies in Primary Membranous Nephropathy

Explore by condition: All Primary Membranous Nephropathy clinical trials

💡 How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
🏛️ View Official NIH Record ↗