A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
PROMINENT
An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]
2 other identifiers
interventional
180
11 countries
102
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started May 2025
Typical duration for phase_3
102 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 30, 2025
CompletedFirst Posted
Study publicly available on registry
May 8, 2025
CompletedStudy Start
First participant enrolled
May 22, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 29, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 29, 2029
June 12, 2026
June 1, 2026
3.6 years
April 30, 2025
June 11, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants who Achieve Complete Remission (CR) at Week 104
Week 104
Secondary Outcomes (12)
Percentage of Participants who Achieve Overall Remission (OR), Defined as CR or Partial Remission (PR) at Week 104
Week 104
Percentage of Participants who Achieve CR at Week 76
Week 76
Duration of CR
Baseline up to week 156
Percentage of Participants With a Baseline Anti-Phospholipase A2 Receptor (PLA2R) Autoantibody Titer Greater Than 50 Relative Unit per Milliliter (RU/mL) who Achieve an OR at Week 76 and at Week 104
Weeks 76 and 104
Time to Disease Worsening
Baseline up to week 156
- +7 more secondary outcomes
Study Arms (2)
Open-Label Treatment Phase
EXPERIMENTALParticipants will receive several intravenous (IV) doses of felzartamab or oral tacrolimus in the Open-Label Treatment Phase.
Non-Responder Treatment Phase
EXPERIMENTALParticipants initially randomized to felzartamab or tacrolimus who meet rescue criteria may receive regional standard of care immunosuppressive therapy (IST) per Investigator discretion or several IV doses of felzartamab, respectively, in the Non-Responder Treatment Phase.
Interventions
Administered intravenously
Eligibility Criteria
You may qualify if:
- 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 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 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:
- Newly diagnosed PMN, defined as having never received IST for PMN in the past.
- 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 angiotensin-converting enzyme inhibitor (ACEI) or angiotensin receptor blocker (ARB) for at least 3 months prior to Screening. Participants not on the maximally approved dose of renin-angiotensin-aldosterone system (RAAS) inhibition may be enrolled provided there is documented intolerance to maximal RAAS inhibition (e.g., angioedema, development of postural hypotension, lightheadedness, hyperkalemia, etc).
- 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 3 months prior to signing the ICF.
You may not qualify if:
- Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \[SLE\], hepatitis B, hepatitis C, etc).
- Severe renal impairment defined as an eGFR ≤ 30 mL/min/1.73m\^2 at Screening or including the need for dialysis or renal replacement therapy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Biogenlead
Study Sites (102)
Apogee Clinical Research, LLC
Huntsville, Alabama, 35805-4104, United States
The Nephrology Group, Inc. - Fresno
Fresno, California, 93720-2989, United States
Academic Medical Research Institute
Los Angeles, California, 90022, United States
UCSF Medical Center
San Francisco, California, 94143-2205, United States
Stanford University
Stanford, California, 94305-2200, United States
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit, Michigan, 48202-2608, United States
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, 48341, United States
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, 10468, United States
ECU Physicians Nephrology and Hypertension
Greenville, North Carolina, 27834, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716, United States
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, 37923-3624, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37204-3609, United States
Nephrotex Research Group
Dallas, Texas, 75231-0929, United States
University of Texas Medical Branch
League City, Texas, 77573, United States
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, 53792-0001, United States
Organización Médica de Investigación
Buenos Aires, C1015ABO, Argentina
CINME S.A. - Centro de Investigaciones Metabólicas
Buenos Aires, C1056ABI, Argentina
Hospital Italiano de Buenos Aires
Buenos Aires, C1199ABB, Argentina
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, C1425, Argentina
Clínica Privada Vélez Sarsfield
Córdoba, X5016KET, Argentina
Concord Hospital
Concord, New South Wales, 2138, Australia
St George Hospital
Kogarah, New South Wales, 2217, Australia
Liverpool Hospital
Liverpool, New South Wales, 2170, Australia
Westmead Hospital
Westmead, New South Wales, 2145, Australia
Townsville Hospital
Douglas, Queensland, 4814, Australia
Royal Brisbane and Women s Hospital
Herston, Queensland, 4006, Australia
Gold Coast University Hospital
Southport, Queensland, 4215, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, 4215, Australia
Monash Health
Clayton, Victoria, 3168, Australia
Sunshine Hospital - Australia
St Albans, Victoria, 3021, Australia
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, 30150-221, Brazil
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90560-030, Brazil
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, 90610-001, Brazil
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, 14051-140, Brazil
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, 15090-000, Brazil
Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, 05304-000, Brazil
London Health Sciences Centre - Victoria Hospital
London, Ontario, N6A 5W9, Canada
Fu Yang People's Hospital - South Campus
Fuyang, Anhui, 236006, China
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, 102218, China
Peking University First Hospital - Changqiao Campus
Xichengqu Beijing, Beijing Municipality, 100034, China
Zhongshan Hospital Xiamen University
Xiamen, Fujian, 361004, China
Gansu Provincial Hospital
Lanzhou, Gansu, 730000, China
Lanzhou University Second Hospital
Lanzhou, Gansu, 730030, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 510280, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518036, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530021, China
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, 530021, China
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, 550004, China
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, 50000, China
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, 50031, China
Daqing Oilfield General Hospital
Daqing, Heilongjiang, 163001, China
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, 471003, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Yueyang People Hospital
Yueyang, Hunan, 414000, China
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710004, China
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, 710061, China
Qilu Hospital of Shandong University
Jinan, Shandong, 250012, China
The Second Hospital of Shandong University
Jinan, Shandong, 250033, China
The Affiliated Hospital of Qingdao University - Xihaian Campus
Qingdao, Shandong, 266555, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009, China
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, 310016, China
Osmania General Hospital
Hyderabad, Andhra Pradesh, 500012, India
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh, 500082, India
Manipal Hospital Bangalore
Bangalore, Karnataka, 560017, India
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, 560054, India
Noble Hospital
Pune, Maharashtra, 411013, India
Max Super Speciality Hospital - Saket
New Delhi, National Capital Territory of Delhi, 110017, India
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, 110060, India
Regency Health Super Specialty Hospital - Lucknow
Lucknow, Uttar Pradesh, 226022, India
Galaxy Hospital - Varanasi
Varanasi, Uttar Pradesh, 221010, India
Nil Ratan Sircar Medical College and Hospital
Kolkata, West Bengal, 700014, India
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, 160012, India
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chia-shi, Chiba, 260-8712, Japan
Juntendo University Urayasu Hospital
Urayasu-Shi, Chiba, 279-0021, Japan
Hokkaido University Hospital
Sapporo, Hokkaidô, 060-8648, Japan
Kagawa University Hospital
Kita-Gun Uchiko-Cho, Kagawa-ken, 761-0793, Japan
The Kitasato Institute Kitasato University Hospital
Sagamihara-Shi Minami-Ku, Kanagawa, 252-0375, Japan
Yokohama City University Hospital
Yokohama, Kanagawa, 236-0004, Japan
University of Miyazaki Hospital
Miyazaki, Miyazaki, 889-1692, Japan
Niigata University Medical ＆ Dental Hospital
Niigata, Niigata, 951-8520, Japan
Social Medical Corporation Yuuaikai Yuuai Medical Center
Tomigusuku-Shi, Okinawa, 901-0224, Japan
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama, 350-0451, Japan
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, 180-8610, Japan
Hospital Raja Permaisuri Bainun
Perak, Pahang, 30450, Malaysia
Hospital Canselor Tuanku Muhriz UKM
Cheras, WilayahPersekutuan KualaLumpur, 56000, Malaysia
Prince Court Medical Centre
Kuala Lumpur, 50450, Malaysia
Ajou University Hospital
Suwon, Gyeonggido, 16499, South Korea
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, 3080, South Korea
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
Hanyang University Seoul Hospital
Seoul, 4763, South Korea
Chung-Ang University Hospital
Seoul, 6973, South Korea
Hualien Tzu Chi Hospital
Hualien City, Hualien, 970, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, 80756, Taiwan
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, 83301, Taiwan
China Medical University Hospital
Taichung, 40447, Taiwan
Taichung Veterans General Hospital
Taichung, 40705, Taiwan
National Cheng Kung University Hospital
Tainan, 70403, Taiwan
MacKay Memorial Hospital
Taipei, 104, Taiwan
Taipei Medical University Hospital - PPDS
Taipei, 11031, Taiwan
Taipei Municipal Wanfang Hospital
Taipei, 116, Taiwan
Chang Gung Memorial Hospital
Taoyuan, 33305, Taiwan
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Medical Director
Biogen
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 30, 2025
First Posted
May 8, 2025
Study Start
May 22, 2025
Primary Completion (Estimated)
December 29, 2028
Study Completion (Estimated)
March 29, 2029
Last Updated
June 12, 2026
Record last verified: 2026-06
Data Sharing
- IPD Sharing
- Will share
In accordance with Biogen's Clinical Trial Transparency and Data Sharing Policy on https://www.biogentrialtransparency.com/