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New antibody drug aims to protect kidneys in PMN patients

NCT ID NCT06962800

Disease control Sponsor: Biogen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 26, 2026 · Last updated Aug 27, 2026 · Updated 9 times

Summary

This Phase 3 study tests a new drug called felzartamab in 180 people with primary membranous nephropathy (PMN), a kidney disease where the body's immune system attacks the kidneys. Felzartamab is a lab-made antibody designed to stop that attack. The study compares felzartamab to the standard drug tacrolimus. The main goal is to see if more patients achieve complete remission (low urine protein and stable kidney function) after 104 weeks of treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
felzartamab (a lab-made antibody given by IV)
What this could lead to
If successful, felzartamab could offer a new treatment option for people with PMN, potentially reducing kidney damage and delaying or avoiding kidney failure.
What could go wrong
This is a Phase 3 trial, but it's still experimental. Felzartamab may not work better than existing drugs, and side effects are possible. The study is not designed to cure PMN, only to control it.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Started

May 2025

Expected to finish

Jan 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 80 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

idiopathic membranous glomerulonephritis membranous glomerulonephritis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Primary membranous nephropathy

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    111 sites in 11 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Academic Medical Research Institute

    RECRUITING

    Los Angeles, California, 90022, United States

  • Ajou University Hospital

    RECRUITING

    Suwon, Gyeonggido, 16499, South Korea

  • Apogee Clinical Research, LLC

    RECRUITING

    Huntsville, Alabama, 35805-4104, United States

  • Beijing Tsinghua Changgung Hospital

    RECRUITING

    Beijing, Beijing Municipality, 102218, China

  • CINME S.A. - Centro de Investigaciones Metabólicas

    RECRUITING

    Buenos Aires, C1056ABI, Argentina

  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada

    RECRUITING

    Buenos Aires, C1425, Argentina

  • Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo

    RECRUITING

    São Paulo, 05304-000, Brazil

  • Chang Gung Memorial Hospital

    RECRUITING

    Taoyuan, 33305, Taiwan

  • China Medical University Hospital

    RECRUITING

    Taichung, 40447, Taiwan

  • Chung-Ang University Hospital

    RECRUITING

    Seoul, 6973, South Korea

  • Clínica Privada Vélez Sarsfield

    RECRUITING

    Córdoba, X5016KET, Argentina

  • Concord Hospital

    RECRUITING

    Concord, New South Wales, 2138, Australia

  • Daqing Oilfield General Hospital

    RECRUITING

    Daqing, Heilongjiang, 163001, China

  • ECU Physicians Nephrology and Hypertension

    RECRUITING

    Greenville, North Carolina, 27834, United States

  • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS

    COMPLETED

    Pontiac, Michigan, 48341, United States

  • Fu Yang People's Hospital - South Campus

    RECRUITING

    Fuyang, Anhui, 236006, China

  • Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS

    RECRUITING

    São José do Rio Preto, São Paulo, 15090-000, Brazil

  • Galaxy Hospital - Varanasi

    RECRUITING

    Varanasi, Uttar Pradesh, 221010, India

  • Gansu Provincial Hospital

    RECRUITING

    Lanzhou, Gansu, 730000, China

  • Gold Coast University Hospital

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Griffith University Clinical Trial Unit

    RECRUITING

    Southport, Queensland, 4215, Australia

  • Hanyang University Seoul Hospital

    RECRUITING

    Seoul, 4763, South Korea

  • Henry Ford Hospital- A-Basement Research Pharmacy

    RECRUITING

    Detroit, Michigan, 48202-2608, United States

  • Hokkaido University Hospital

    RECRUITING

    Sapporo, Hokkaidô, 060-8648, Japan

  • Hospital Alemao Oswaldo Cruz (HAOC)

    RECRUITING

    São Paulo, 01327-001, Brazil

  • Hospital Canselor Tuanku Muhriz UKM

    RECRUITING

    Cheras, WilayahPersekutuan KualaLumpur, 56000, Malaysia

  • Hospital Italiano de Buenos Aires

    RECRUITING

    Buenos Aires, C1199ABB, Argentina

  • Hospital Raja Permaisuri Bainun

    RECRUITING

    Perak, Pahang, 30450, Malaysia

  • Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90610-001, Brazil

  • Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo

    RECRUITING

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hospital de Clinicas de Porto Alegre

    RECRUITING

    Porto Alegre, Rio Grande do Sul, 90560-030, Brazil

  • Hualien Tzu Chi Hospital

    RECRUITING

    Hualien City, Hualien, 970, Taiwan

  • Huashan Hospital Fudan University

    RECRUITING

    Shanghai, Shanghai Municipality, 200040, China

  • Inje University Haeundae Paik Hospital

    RECRUITING

    Busan, 48108, South Korea

  • James J Peters Veterans Administration Medical Center - NAVREF - PPDS

    RECRUITING

    The Bronx, New York, 10468, United States

  • Japanese Red Cross Musashino Hospital

    RECRUITING

    Musashino-shi, Tokyo, 180-8610, Japan

  • Juntendo University Urayasu Hospital

    RECRUITING

    Urayasu-Shi, Chiba, 279-0021, Japan

  • Kagawa University Hospital

    RECRUITING

    Kita-Gun Uchiko-Cho, Kagawa-ken, 761-0793, Japan

  • Kaohsiung Chang Gung Memorial Hospital

    RECRUITING

    Kaohsiung City, 83301, Taiwan

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    RECRUITING

    Kaohsiung City, 80756, Taiwan

  • Knoxville Kidney Center, PLLC

    RECRUITING

    Knoxville, Tennessee, 37923-3624, United States

  • Lanzhou University Second Hospital

    RECRUITING

    Lanzhou, Gansu, 730030, China

  • Liverpool Hospital

    RECRUITING

    Liverpool, New South Wales, 2170, Australia

  • London Health Sciences Centre - Victoria Hospital

    RECRUITING

    London, Ontario, N6A 5W9, Canada

  • M.S. Ramaiah Medical College and Hospital

    RECRUITING

    Bangalore, Karnataka, 560054, India

  • MacKay Memorial Hospital

    RECRUITING

    Taipei, 104, Taiwan

  • Manipal Hospital Bangalore

    RECRUITING

    Bangalore, Karnataka, 560017, India

  • Max Super Speciality Hospital - Saket

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110017, India

  • Monash Health

    RECRUITING

    Clayton, Victoria, 3168, Australia

  • National Cheng Kung University Hospital

    RECRUITING

    Tainan, 70403, Taiwan

  • National Hospital Organization Chiba Medical Center Chibahigashi National Hospital

    RECRUITING

    Chia-shi, Chiba, 260-8712, Japan

  • Nephrotex Research Group

    RECRUITING

    Dallas, Texas, 75231-0929, United States

  • Niigata University Medical ＆ Dental Hospital

    RECRUITING

    Niigata, Niigata, 951-8520, Japan

  • Nil Ratan Sircar Medical College and Hospital

    RECRUITING

    Kolkata, West Bengal, 700014, India

  • Nizams Institute of Medical Sciences

    RECRUITING

    Hyderabad, Andhra Pradesh, 500082, India

  • Noble Hospital

    RECRUITING

    Pune, Maharashtra, 411013, India

  • Organización Médica de Investigación

    RECRUITING

    Buenos Aires, C1015ABO, Argentina

  • Osmania General Hospital

    RECRUITING

    Hyderabad, Andhra Pradesh, 500012, India

  • Peking University First Hospital - Changqiao Campus

    RECRUITING

    Xichengqu Beijing, Beijing Municipality, 100034, China

  • Peking University Shenzhen Hospital

    RECRUITING

    Shenzhen, Guangdong, 518036, China

  • Postgraduate Institute of Medical Education & Research (PGIMER)

    RECRUITING

    Chandigarh, 160012, India

  • Prince Court Medical Centre

    RECRUITING

    Kuala Lumpur, 50450, Malaysia

  • Qilu Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250012, China

  • Regency Health Super Specialty Hospital - Lucknow

    RECRUITING

    Lucknow, Uttar Pradesh, 226022, India

  • Royal Brisbane and Women s Hospital

    RECRUITING

    Herston, Queensland, 4006, Australia

  • Ruijin Hospital Shanghai Jiaotong University School of Medicine

    RECRUITING

    Shanghai, Shanghai Municipality, 200025, China

  • Saitama Medical University Hospital

    RECRUITING

    Iruma-Gun Moroyama-Machi, Saitama, 350-0451, Japan

  • Sanjay Gandhi Postgraduate Institute of Medical Sciences

    RECRUITING

    Lucknow, Uttar Pradesh, 226014, India

  • Santa Casa de Misericórdia de Belo Horizonte

    RECRUITING

    Belo Horizonte, Minas Gerais, 30150-221, Brazil

  • Seoul National University Hospital

    RECRUITING

    Seoul, Seoul Teugbyeolsi, 3080, South Korea

  • Shenzhen Hospital of Southern Medical University

    RECRUITING

    Shenzhen, Guangdong, 510086, China

  • Sir Ganga Ram Hospital

    RECRUITING

    New Delhi, National Capital Territory of Delhi, 110060, India

  • Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus

    RECRUITING

    Hangzhou, Zhejiang, 310016, China

  • Social Medical Corporation Yuuaikai Yuuai Medical Center

    RECRUITING

    Tomigusuku-Shi, Okinawa, 901-0224, Japan

  • St George Hospital

    RECRUITING

    Kogarah, New South Wales, 2217, Australia

  • Stanford University

    RECRUITING

    Stanford, California, 94305-2200, United States

  • Sunshine Hospital - Australia

    RECRUITING

    St Albans, Victoria, 3021, Australia

  • Taichung Veterans General Hospital

    RECRUITING

    Taichung, 40705, Taiwan

  • Taipei Medical University Hospital - PPDS

    RECRUITING

    Taipei, 11031, Taiwan

  • Taipei Municipal Wanfang Hospital

    RECRUITING

    Taipei, 116, Taiwan

  • The Affiliated Hospital of Guizhou Medical University

    RECRUITING

    Guiyang, Guizhou, 550004, China

  • The Affiliated Hospital of Qingdao University - Xihaian Campus

    RECRUITING

    Qingdao, Shandong, 266555, China

  • The First Affiliated Hospital of Guangxi Medical University

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus

    RECRUITING

    Luoyang, Henan, 471003, China

  • The First Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710061, China

  • The First Affiliated Hospital, Zhejiang University School of Medicine - Qingchun Campus - PPDS

    RECRUITING

    Hangzhou, Zhejiang, 310003, China

  • The First Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 50031, China

  • The Kitasato Institute Kitasato University Hospital

    RECRUITING

    Sagamihara-Shi Minami-Ku, Kanagawa, 252-0375, Japan

  • The Nephrology Group, Inc. - Fresno

    RECRUITING

    Fresno, California, 93720-2989, United States

  • The People's Hospital of Guangxi Zhuang Autonomous Region

    RECRUITING

    Nanning, Guangxi, 530021, China

  • The Second Affiliated Hospital of Nanjing Medical University - Main Campus

    RECRUITING

    Nanjing, Jiangsu, 210011, China

  • The Second Affiliated Hospital of Xian Jiaotong University

    RECRUITING

    Xi'an, Shaanxi, 710004, China

  • The Second Affiliated Hospital, Zhejiang University School of Medicine

    RECRUITING

    Hangzhou, Zhejiang, 310009, China

  • The Second Hospital of Hebei Medical University - Main

    RECRUITING

    Shijiazhuang, Hebei, 50000, China

  • The Second Hospital of Shandong University

    RECRUITING

    Jinan, Shandong, 250033, China

  • The Second Xiangya Hospital of Central South University

    RECRUITING

    Changsha, Hunan, 410011, China

  • Townsville Hospital

    RECRUITING

    Douglas, Queensland, 4814, Australia

  • UCLA Health Connie Frank Kidney Transplant Center and General Nephrology

    RECRUITING

    Los Angeles, California, 90095-8344, United States

  • UCSF Medical Center

    RECRUITING

    San Francisco, California, 94143-2205, United States

  • University Hospitals Cleveland Medical Center

    RECRUITING

    Cleveland, Ohio, 44106-1716, United States

  • University of Miyazaki Hospital

    RECRUITING

    Miyazaki, Miyazaki, 889-1692, Japan

  • University of Texas Medical Branch

    RECRUITING

    League City, Texas, 77573, United States

  • University of Wisconsin School of Medicine and Public Health

    RECRUITING

    Madison, Wisconsin, 53792-0001, United States

  • Vancouver Coastal Health Research Institute

    RECRUITING

    Vancouver, British Columbia, V5Z 1M9, Canada

  • Vanderbilt University Medical Center

    RECRUITING

    Nashville, Tennessee, 37204-3609, United States

  • Westmead Hospital

    RECRUITING

    Westmead, New South Wales, 2145, Australia

  • Yantai Yuhuangding Hospital

    RECRUITING

    Yantai, Shandong, 264000, China

  • Yichang Central People's Hospital - Wujiagang Campus

    RECRUITING

    Yichang, Hubei, 443003, China

  • Yokohama City University Hospital

    RECRUITING

    Yokohama, Kanagawa, 236-0004, Japan

  • Yueyang People Hospital

    RECRUITING

    Yueyang, Hunan, 414000, China

  • Zhongshan Hospital Xiamen University

    RECRUITING

    Xiamen, Fujian, 361004, China

  • Zhujiang Hospital of Southern Medical University

    RECRUITING

    Guangzhou, Guangdong, 510280, China

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