Actively Recruiting
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
Led by Biogen · Updated on 2026-05-05
180
Participants Needed
93
Research Sites
201 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with primary membranous nephropathy requiring immunosuppressive therapy as judged by the investigator
- Diagnosis confirmed by kidney biopsy during screening or within 5 years, or positive anti-PLA2R antibody test with no secondary causes
- Either newly diagnosed without prior immunosuppressive treatment or relapsed disease after prior treatment
- On maximum or tolerated dose of ACE inhibitor or angiotensin receptor blocker for at least 3 months before screening
- Urine protein to creatinine ratio of 3.0 g/g or higher, or total proteinuria of 3.5 g/24 h or more after supportive care for at least 3 months
- Age between 18 and 80 years
You will not qualify if you...
- Secondary causes of membranous nephropathy such as cancer, medications, lupus, hepatitis B or C
- Severe kidney impairment with estimated glomerular filtration rate 30 mL/min/1.73m2 or less, or need for dialysis or kidney replacement therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 93 locations
1
Apogee Clinical Research, LLC
Huntsville, Alabama, United States, 35805-4104
Actively Recruiting
2
The Nephrology Group, Inc. - Fresno
Fresno, California, United States, 93720-2989
Actively Recruiting
3
Academic Medical Research Institute
Los Angeles, California, United States, 90022
Actively Recruiting
4
UCSF Medical Center
San Francisco, California, United States, 94143-2205
Actively Recruiting
5
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit, Michigan, United States, 48202-2608
Actively Recruiting
6
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, United States, 48341
Completed
7
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, United States, 10468
Actively Recruiting
8
ECU Physicians Nephrology and Hypertension
Greenville, North Carolina, United States, 27834
Actively Recruiting
9
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States, 37923-3624
Actively Recruiting
10
Nephrotex Research Group
Dallas, Texas, United States, 75231-0929
Actively Recruiting
11
University of Texas Medical Branch
League City, Texas, United States, 77573
Actively Recruiting
12
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792-0001
Actively Recruiting
13
Organización Médica de Investigación
Buenos Aires, Argentina, C1015ABO
Actively Recruiting
14
CINME S.A. - Centro de Investigaciones Metabólicas
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
15
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABB
Actively Recruiting
16
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina, C1425
Actively Recruiting
17
Clínica Privada Vélez Sarsfield
Córdoba, Argentina, X5016KET
Actively Recruiting
18
Concord Hospital
Concord, New South Wales, Australia, 2138
Actively Recruiting
19
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
20
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
21
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
22
Townsville Hospital
Douglas, Queensland, Australia, 4814
Actively Recruiting
23
Royal Brisbane and Women s Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
24
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
25
Griffith University Clinical Trial Unit
Southport, Queensland, Australia, 4215
Actively Recruiting
26
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
27
Sunshine Hospital - Australia
St Albans, Victoria, Australia, 3021
Actively Recruiting
28
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Actively Recruiting
29
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
Actively Recruiting
30
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil, 90610-001
Actively Recruiting
31
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14051-140
Actively Recruiting
32
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil, 15090-000
Actively Recruiting
33
Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil, 05304-000
Actively Recruiting
34
Fu Yang People's Hospital - South Campus
Fuyang, Anhui, China, 236006
Actively Recruiting
35
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
36
Peking University First Hospital - Changqiao Campus
Xichengqu Beijing, Beijing Municipality, China, 100034
Actively Recruiting
37
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
38
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
39
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
Actively Recruiting
40
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
41
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
42
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
43
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Actively Recruiting
44
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
45
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, China, 50000
Actively Recruiting
46
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 50031
Actively Recruiting
47
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 163001
Actively Recruiting
48
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, China, 471003
Actively Recruiting
49
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
50
Yueyang People Hospital
Yueyang, Hunan, China, 414000
Actively Recruiting
51
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
52
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
53
The Second Hospital of Shandong University
Jinan, Shandong, China, 250033
Actively Recruiting
54
The Affiliated Hospital of Qingdao University - Xihaian Campus
Qingdao, Shandong, China, 266555
Actively Recruiting
55
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Actively Recruiting
56
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
57
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
58
Osmania General Hospital
Hyderabad, Andhra Pradesh, India, 500012
Actively Recruiting
59
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500082
Actively Recruiting
60
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India, 560054
Actively Recruiting
61
Noble Hospital
Pune, Maharashtra, India, 411013
Actively Recruiting
62
Max Super Speciality Hospital - Saket
New Delhi, National Capital Territory of Delhi, India, 110017
Actively Recruiting
63
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
64
Galaxy Hospital - Varanasi
Varanasi, Uttar Pradesh, India, 221010
Actively Recruiting
65
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, India, 160012
Actively Recruiting
66
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chia-shi, Chiba, Japan, 260-8712
Actively Recruiting
67
Juntendo University Urayasu Hospital
Urayasu-Shi, Chiba, Japan, 279-0021
Actively Recruiting
68
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan, 060-8648
Actively Recruiting
69
Kagawa University Hospital
Kita-Gun Uchiko-Cho, Kagawa-ken, Japan, 761-0793
Actively Recruiting
70
The Kitasato Institute Kitasato University Hospital
Sagamihara-Shi Minami-Ku, Kanagawa, Japan, 252-0375
Actively Recruiting
71
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
72
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan, 889-1692
Actively Recruiting
73
Niigata University Medical ＆ Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
74
Social Medical Corporation Yuuaikai Yuuai Medical Center
Tomigusuku-Shi, Okinawa, Japan, 901-0224
Actively Recruiting
75
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama, Japan, 350-0451
Actively Recruiting
76
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, Japan, 180-8610
Actively Recruiting
77
Hospital Raja Permaisuri Bainun
Perak, Pahang, Malaysia, 30450
Actively Recruiting
78
Hospital Canselor Tuanku Muhriz UKM
Cheras, WilayahPersekutuan KualaLumpur, Malaysia, 56000
Actively Recruiting
79
Prince Court Medical Centre
Kuala Lumpur, Malaysia, 50450
Actively Recruiting
80
Ajou University Hospital
Suwon, Gyeonggido, South Korea, 16499
Actively Recruiting
81
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
82
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
83
Hanyang University Seoul Hospital
Seoul, South Korea, 4763
Actively Recruiting
84
Chung-Ang University Hospital
Seoul, South Korea, 6973
Actively Recruiting
85
Hualien Tzu Chi Hospital
Hualien City, Hualien, Taiwan, 970
Actively Recruiting
86
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
87
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
88
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
89
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
90
MacKay Memorial Hospital
Taipei, Taiwan, 104
Actively Recruiting
91
Taipei Medical University Hospital - PPDS
Taipei, Taiwan, 11031
Actively Recruiting
92
Taipei Municipal Wanfang Hospital
Taipei, Taiwan, 116
Actively Recruiting
93
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
CONTACT
G
Global Biogen Clinical Trial Center
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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