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RECRUITING Phase 3 ClinicalTrials.gov

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

Sponsor: Biogen • ClinicalTrials.gov ID: NCT06962800

Registry updated: 2026-09-29
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Description

In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN. In people with PMN, autoantibodies build up in the glomeruli of the kidney. Antibodies are proteins that help the body fight off infection. An autoantibody is a type of antibody that mistakenly targets and attacks the body's own tissues. Glomeruli are the filters of the kidney that remove waste and extra fluid from the body. In PMN, the build-up of autoantibodies in the glomeruli causes damage to the kidneys. Kidney damage can lead to too much protein and blood leaking into the urine. High levels of protein in the urine, called proteinuria, are common in people with PMN. Symptoms of PMN can include swelling in the legs and body, tiredness, and high blood pressure. If left untreated, PMN can eventually lead to kidney failure. In this study, researchers will learn more about how a study drug called felzartamab affects people with PMN. Felzartamab is a monoclonal antibody, which means it is an antibody made in a laboratory. Felzartamab can target immune cells that produce autoantibodies, helping to lower their buildup in the kidneys. The main goal of this study is to compare how felzartamab works compared to a drug called tacrolimus. Tacrolimus is another drug given to people with PMN and kidney disease. The main question that researchers want to answer is: * How many participants achieve a complete response after 104 weeks of treatment? * A complete response means that their urine protein levels decrease to a low level and their kidney function remains stable. Researchers will also learn about: * How long it takes before the participants' disease gets worse * How long the participants' urine protein levels stay low * How many participants develop antibodies against felzartamab in the blood? * How many participants achieve a complete response after 76 weeks of treatment * How many participants have medical problems during the study * How felzartamab is processed by the body * How felzartamab affects participants' tiredness and overall physical health The study will be done as follows: * Participants will be screened to check if they can join the study. This may take up to 42 days. * Participants will be randomized to receive either felzartamab as intravenous (IV) infusions or tacrolimus, taken orally as tablets. * If participants have worsening kidney function or worsening proteinuria, or if their PMN relapses, or if they show no signs of improvement in their PMN, they will have a chance to receive rescue treatment. * If a participant stops treatment early, there will be follow-up visits every 12 weeks until they reach Week 104. * In total, participants will have up to 23 study visits. Participants who do not need rescue treatment will stay in the study for up to 104 weeks. Participants who need rescue treatment will stay in the study for up to 156 weeks.

Interventions

  • Felzartamab (Drug)
    Administered intravenously
  • Tacrolimus (Drug)
    Administered orally
  • Standard of Care IST (Drug)
    Administered intravenously and orally

Eligibility criteria

Key Inclusion Criteria: * Diagnosed with PMN in need of IST according to the Investigator's clinical judgment. The diagnosis of PMN must be documented with the presence of nephrotic syndrome, and hypoalbuminemia, and confirmed with a kidney biopsy either during Screening or within 5 years of signing the informed consent form (ICF) \[see kidney biopsy exception below for participants positive for anti-PLA2R antibodies\]. For these participants, the biopsy report with redacted protected health information must be available to be reviewed by the Sponsor or an independent nephropathologist. If the participant requires a kidney biopsy during Screening, medical monitor approval must be obtained, and all other eligibility criteria should be reviewed to ensure that the participant is otherwise eligible prior to performing the kidney biopsy. a. Kidney biopsy exception for anti-PLA2R antibody positive participants: Participants who are positive for anti-PLA2R antibodies at Screening and have not had a kidney biopsy performed within 5 years of signing the ICF may be eligible for the study without undergoing a kidney biopsy based on medical monitor review of screening tests confirming normal estimated glomerular filtration rate (eGFR), presence of nephrotic syndrome, hypoalbuminemia, positive anti-PLA2R antibody test (defined as an anti-PLA2R antibody titer ≥ 20 RU/mL), and documentation provided by the Investigator that the work-up for secondary causes of membranous nephropathy (MN) was negative with no identifiable secondary causes. * Meets one of the following: 1. Newly diagnosed PMN, defined as having never received IST for PMN in the past. 2. Relapsed PMN, defined as documented achievement of CR or partial remission (PR) after treatment with an IST for PMN followed by reappearance of nephrotic range proteinuria (urine protein to creatinine ratio \[UPCR\] ≥ 3.0 gram per gram \[g/g\] from a 24-hour urine collection or proteinuria ≥ 3.5 gram per 24 hour \[g/24 h\]). * Participants must be on the maximally approved dose or maximally tolerated dose of at least one renin-angiotensin-aldosterone system (RAAS) inhibition therapy (e.g. angiotensin-converting enzyme inhibitor \[ACEI\], angiotensin receptor blocker \[ARB\], and/or mineralocorticoid receptor antagonists \[MRA\]) for at least 4 weeks prior to Screening. Participants not on the maximally approved dose of RAAS inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc). Participants on MRA therapy alone at Screening must have documented prior intolerance of ACEI or ARB therapy. Participants who do not tolerate ACEI or ARB therapy are not required to start MRA therapy prior to Screening. * A UPCR of ≥ 3.0 g/g (as determined by a 24-hour urine collection) or total proteinuria ≥ 3.5 g/24 h (as determined by a 24-hour urine collection) at Screening after best supportive care for at least 4 weeks prior to signing the ICF. Key Exclusion Criteria: * Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \[SLE\], hepatitis B, hepatitis C, etc). * Severe renal impairment is defined as an eGFR ≤ 30 mL/min/1.73m\^2 at Screening or including the need for dialysis or renal replacement therapy. Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Conditions

Primary Membranous Nephropathy

Locations

  • Apogee Clinical Research, LLC — Huntsville, Alabama, United States
  • The Nephrology Group, Inc. - Fresno — Fresno, California, United States
  • Academic Medical Research Institute — Los Angeles, California, United States
  • UCLA Health Connie Frank Kidney Transplant Center and General Nephrology — Los Angeles, California, United States
  • UCSF Medical Center — San Francisco, California, United States
  • Stanford University — Stanford, California, United States
  • Henry Ford Hospital- A-Basement Research Pharmacy — Detroit, Michigan, United States
  • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS — Pontiac, Michigan, United States
  • James J Peters Veterans Administration Medical Center - NAVREF - PPDS — The Bronx, New York, United States
  • ECU Physicians Nephrology and Hypertension — Greenville, North Carolina, United States
  • University Hospitals Cleveland Medical Center — Cleveland, Ohio, United States
  • Knoxville Kidney Center, PLLC — Knoxville, Tennessee, United States
  • Vanderbilt University Medical Center — Nashville, Tennessee, United States
  • Nephrotex Research Group — Dallas, Texas, United States
  • University of Texas Medical Branch — League City, Texas, United States
  • University of Wisconsin School of Medicine and Public Health — Madison, Wisconsin, United States
  • Organización Médica de Investigación — Buenos Aires, Argentina
  • CINME S.A. - Centro de Investigaciones Metabólicas — Buenos Aires, Argentina
  • Hospital Italiano de Buenos Aires — Buenos Aires, Argentina
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada — Buenos Aires, Argentina
  • Clínica Privada Vélez Sarsfield — Córdoba, Argentina
  • Concord Hospital — Concord, New South Wales, Australia
  • St George Hospital — Kogarah, New South Wales, Australia
  • Liverpool Hospital — Liverpool, New South Wales, Australia
  • Westmead Hospital — Westmead, New South Wales, Australia
  • Townsville Hospital — Douglas, Queensland, Australia
  • Royal Brisbane and Women s Hospital — Herston, Queensland, Australia
  • Gold Coast University Hospital — Southport, Queensland, Australia
  • Griffith University Clinical Trial Unit — Southport, Queensland, Australia
  • Monash Health — Clayton, Victoria, Australia
  • Sunshine Hospital - Australia — St Albans, Victoria, Australia
  • Santa Casa de Misericórdia de Belo Horizonte — Belo Horizonte, Minas Gerais, Brazil
  • Hospital de Clinicas de Porto Alegre — Porto Alegre, Rio Grande do Sul, Brazil
  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) — Porto Alegre, Rio Grande do Sul, Brazil
  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo — Ribeirão Preto, São Paulo, Brazil
  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS — São José do Rio Preto, São Paulo, Brazil
  • Hospital Alemao Oswaldo Cruz (HAOC) — São Paulo, Brazil
  • Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo — São Paulo, Brazil
  • Vancouver Coastal Health Research Institute — Vancouver, British Columbia, Canada
  • London Health Sciences Centre - Victoria Hospital — London, Ontario, Canada
  • Fu Yang People's Hospital - South Campus — Fuyang, Anhui, China
  • Beijing Tsinghua Changgung Hospital — Beijing, Beijing Municipality, China
  • Peking University First Hospital - Changqiao Campus — Xichengqu Beijing, Beijing Municipality, China
  • Zhongshan Hospital Xiamen University — Xiamen, Fujian, China
  • Gansu Provincial Hospital — Lanzhou, Gansu, China
  • Lanzhou University Second Hospital — Lanzhou, Gansu, China
  • Zhujiang Hospital of Southern Medical University — Guangzhou, Guangdong, China
  • Shenzhen Hospital of Southern Medical University — Shenzhen, Guangdong, China
  • Peking University Shenzhen Hospital — Shenzhen, Guangdong, China
  • The First Affiliated Hospital of Guangxi Medical University — Nanning, Guangxi, China
  • The People's Hospital of Guangxi Zhuang Autonomous Region — Nanning, Guangxi, China
  • The Affiliated Hospital of Guizhou Medical University — Guiyang, Guizhou, China
  • The Second Hospital of Hebei Medical University - Main — Shijiazhuang, Hebei, China
  • The First Hospital of Hebei Medical University — Shijiazhuang, Hebei, China
  • Daqing Oilfield General Hospital — Daqing, Heilongjiang, China
  • The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus — Luoyang, Henan, China
  • Yichang Central People's Hospital - Wujiagang Campus — Yichang, Hubei, China
  • The Second Xiangya Hospital of Central South University — Changsha, Hunan, China
  • Yueyang People Hospital — Yueyang, Hunan, China
  • The Second Affiliated Hospital of Nanjing Medical University - Main Campus — Nanjing, Jiangsu, China
  • The Second Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
  • The First Affiliated Hospital of Xian Jiaotong University — Xi'an, Shaanxi, China
  • Qilu Hospital of Shandong University — Jinan, Shandong, China
  • The Second Hospital of Shandong University — Jinan, Shandong, China
  • The Affiliated Hospital of Qingdao University - Xihaian Campus — Qingdao, Shandong, China
  • Yantai Yuhuangding Hospital — Yantai, Shandong, China
  • Ruijin Hospital Shanghai Jiaotong University School of Medicine — Shanghai, Shanghai Municipality, China
  • Huashan Hospital Fudan University — Shanghai, Shanghai Municipality, China
  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS — Hangzhou, Zhejiang, China
  • The Second Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou, Zhejiang, China
  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus — Hangzhou, Zhejiang, China
  • The First Affiliated Hospital of Ningbo University - Yuehu Campus — Ningbo, Zhejiang, China
  • Osmania General Hospital — Hyderabad, Andhra Pradesh, India
  • Nizams Institute of Medical Sciences — Hyderabad, Andhra Pradesh, India
  • Manipal Hospital Bangalore — Bangalore, Karnataka, India
  • M.S. Ramaiah Medical College and Hospital — Bangalore, Karnataka, India
  • Noble Hospital — Pune, Maharashtra, India
  • Max Super Speciality Hospital - Saket — New Delhi, National Capital Territory of Delhi, India
  • Sir Ganga Ram Hospital — New Delhi, National Capital Territory of Delhi, India
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, Uttar Pradesh, India
  • Regency Health Super Specialty Hospital - Lucknow — Lucknow, Uttar Pradesh, India
  • Galaxy Hospital - Varanasi — Varanasi, Uttar Pradesh, India
  • Nil Ratan Sircar Medical College and Hospital — Kolkata, West Bengal, India
  • Postgraduate Institute of Medical Education & Research (PGIMER) — Chandigarh, India
  • National Hospital Organization Chiba Medical Center Chibahigashi National Hospital — Chia-shi, Chiba, Japan
  • Juntendo University Urayasu Hospital — Urayasu-Shi, Chiba, Japan
  • Hokkaido University Hospital — Sapporo, Hokkaidô, Japan
  • Kagawa University Hospital — Kita-Gun Uchiko-Cho, Kagawa-ken, Japan
  • The Kitasato Institute Kitasato University Hospital — Sagamihara-Shi Minami-Ku, Kanagawa, Japan
  • Yokohama City University Hospital — Yokohama, Kanagawa, Japan
  • University of Miyazaki Hospital — Miyazaki, Miyazaki, Japan
  • Niigata University Medical ＆ Dental Hospital — Niigata, Niigata, Japan
  • Social Medical Corporation Yuuaikai Yuuai Medical Center — Tomigusuku-Shi, Okinawa, Japan
  • The University of Osaka Hospital — Suita-Shi, Osaka, Japan
  • Saitama Medical University Hospital — Iruma-Gun Moroyama-Machi, Saitama, Japan
  • Japanese Red Cross Musashino Hospital — Musashino-shi, Tokyo, Japan
  • Hospital Raja Permaisuri Bainun — Perak, Pahang, Malaysia
  • Hospital Canselor Tuanku Muhriz UKM — Cheras, WilayahPersekutuan KualaLumpur, Malaysia
  • Prince Court Medical Centre — Kuala Lumpur, Malaysia
  • Ajou University Hospital — Suwon, Gyeonggido, South Korea
  • Seoul National University Hospital — Seoul, Seoul Teugbyeolsi, South Korea
  • Inje University Haeundae Paik Hospital — Busan, South Korea
  • Hanyang University Seoul Hospital — Seoul, South Korea
  • Chung-Ang University Hospital — Seoul, South Korea
  • Hualien Tzu Chi Hospital — Hualien City, Hualien, Taiwan
  • Kaohsiung Medical University Chung-Ho Memorial Hospital — Kaohsiung City, Taiwan
  • Kaohsiung Chang Gung Memorial Hospital — Kaohsiung City, Taiwan
  • China Medical University Hospital — Taichung, Taiwan
  • Taichung Veterans General Hospital — Taichung, Taiwan
  • National Cheng Kung University Hospital — Tainan, Taiwan
  • MacKay Memorial Hospital — Taipei, Taiwan
  • Taipei Medical University Hospital - PPDS — Taipei, Taiwan
  • Taipei Municipal Wanfang Hospital — Taipei, Taiwan
  • Chang Gung Memorial Hospital — Taoyuan, Taiwan
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record