Actively Recruiting
An Open-Label, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab Compared to Tacrolimus in Adults With Primary Membranous Nephropathy
Led by Biogen · Updated on 2026-06-08
180
Participants Needed
100
Research Sites
12 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying primary membranous nephropathy (PMN), a kidney condition where autoantibodies build up in the filters of the kidney, causing damage and leading to symptoms such as swelling, tiredness, and high blood pressure. This trial compares the effects of felzartamab, a laboratory-made monoclonal antibody targeting immune cells that produce harmful autoantibodies, with tacrolimus, a drug commonly given to people with PMN. The study aims to learn how many participants achieve complete remission, where urine protein levels drop and kidney function stays stable, after 104 weeks of treatment. Participants will be randomly assigned to receive either felzartamab through intravenous infusions or tacrolimus as oral tablets during the open-label treatment phase. Those whose condition worsens or does not improve may receive rescue treatment, including standard immunosuppressive therapy or additional felzartamab doses. The study includes a screening period of up to 42 days, followed by treatment and follow-up visits extending up to 156 weeks for some participants. During the study, participants will have up to 23 visits for assessments including urine protein levels, kidney function, antibody presence, and physical health questionnaires. Researchers will monitor treatment effects, safety, and how felzartamab is processed in the body. Follow-up visits will continue every 12 weeks for participants who stop treatment early, ensuring thorough observation up to the study's end at week 104 or beyond if rescue treatment is needed.
CONDITIONS
Brief 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 (PMN) needing immunosuppressive therapy as judged by the Investigator
- Diagnosis confirmed by kidney biopsy within 5 years or by positive anti-PLA2R antibodies with supportive clinical findings
- Newly diagnosed or relapsed PMN with documented remission and recurrence
- On maximum or tolerated dose of ACE inhibitor or angiotensin receptor blocker for at least 3 months prior to screening
- Proteinuria with urine protein to creatinine ratio 23.0 g/g or total proteinuria 23.5 g/24 h 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 malignancies, medications, lupus, hepatitis B or C
- Severe kidney impairment with eGFR 23; 30 mL/min/1.73m or need for dialysis or renal replacement therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 104 weeks
Participants receive several intravenous doses of felzartamab or oral tacrolimus as treatment for primary membranous nephropathy.
Multiple visits for treatment and assessments over the treatment period
Duration - Duration varies depending on response and investigator discretion
Participants who do not respond to initial treatment may receive regional standard of care immunosuppressive therapy or additional felzartamab doses.
Visits as needed based on treatment adjustments
Duration - Up to 52 weeks following treatment (up to week 156 total)
Participants are monitored for safety, efficacy, and long-term outcomes after treatment completion.
Periodic visits for assessments during follow-up
Trial Site Locations
Total: 100 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
Stanford University
Stanford, California, United States, 94305-2200
Actively Recruiting
6
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit, Michigan, United States, 48202-2608
Actively Recruiting
7
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, United States, 48341
Completed
8
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, United States, 10468
Actively Recruiting
9
ECU Physicians Nephrology and Hypertension
Greenville, North Carolina, United States, 27834
Actively Recruiting
10
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States, 44106-1716
Actively Recruiting
11
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States, 37923-3624
Actively Recruiting
12
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204-3609
Actively Recruiting
13
Nephrotex Research Group
Dallas, Texas, United States, 75231-0929
Actively Recruiting
14
University of Texas Medical Branch
League City, Texas, United States, 77573
Actively Recruiting
15
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States, 53792-0001
Actively Recruiting
16
Organización Médica de Investigación
Buenos Aires, Argentina, C1015ABO
Actively Recruiting
17
CINME S.A. - Centro de Investigaciones Metabólicas
Buenos Aires, Argentina, C1056ABI
Actively Recruiting
18
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina, C1199ABB
Actively Recruiting
19
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina, C1425
Actively Recruiting
20
Clínica Privada Vélez Sarsfield
Córdoba, Argentina, X5016KET
Actively Recruiting
21
Concord Hospital
Concord, New South Wales, Australia, 2138
Actively Recruiting
22
St George Hospital
Kogarah, New South Wales, Australia, 2217
Actively Recruiting
23
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Actively Recruiting
24
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Actively Recruiting
25
Townsville Hospital
Douglas, Queensland, Australia, 4814
Actively Recruiting
26
Royal Brisbane and Women s Hospital
Herston, Queensland, Australia, 4006
Actively Recruiting
27
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Actively Recruiting
28
Griffith University Clinical Trial Unit
Southport, Queensland, Australia, 4215
Actively Recruiting
29
Monash Health
Clayton, Victoria, Australia, 3168
Actively Recruiting
30
Sunshine Hospital - Australia
St Albans, Victoria, Australia, 3021
Actively Recruiting
31
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil, 30150-221
Actively Recruiting
32
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil, 90560-030
Actively Recruiting
33
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil, 90610-001
Actively Recruiting
34
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil, 14051-140
Actively Recruiting
35
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
36
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
37
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada, N6A 5W9
Actively Recruiting
38
Fu Yang People's Hospital - South Campus
Fuyang, Anhui, China, 236006
Actively Recruiting
39
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China, 102218
Actively Recruiting
40
Peking University First Hospital - Changqiao Campus
Xichengqu Beijing, Beijing Municipality, China, 100034
Actively Recruiting
41
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China, 361004
Actively Recruiting
42
Gansu Provincial Hospital
Lanzhou, Gansu, China, 730000
Actively Recruiting
43
Lanzhou University Second Hospital
Lanzhou, Gansu, China, 730030
Actively Recruiting
44
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China, 510280
Actively Recruiting
45
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518036
Actively Recruiting
46
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530021
Actively Recruiting
47
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China, 530021
Actively Recruiting
48
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550004
Actively Recruiting
49
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, China, 50000
Actively Recruiting
50
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 50031
Actively Recruiting
51
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China, 163001
Actively Recruiting
52
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, China, 471003
Actively Recruiting
53
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Actively Recruiting
54
Yueyang People Hospital
Yueyang, Hunan, China, 414000
Actively Recruiting
55
The Second Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710004
Actively Recruiting
56
The First Affiliated Hospital of Xian Jiaotong University
Xi'an, Shaanxi, China, 710061
Actively Recruiting
57
Qilu Hospital of Shandong University
Jinan, Shandong, China, 250012
Actively Recruiting
58
The Second Hospital of Shandong University
Jinan, Shandong, China, 250033
Actively Recruiting
59
The Affiliated Hospital of Qingdao University - Xihaian Campus
Qingdao, Shandong, China, 266555
Actively Recruiting
60
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Actively Recruiting
61
The Second Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
62
Sir Run Run Shaw Hospital Zhejiang University School of Medicine - Qingchun Campus
Hangzhou, Zhejiang, China, 310016
Actively Recruiting
63
Osmania General Hospital
Hyderabad, Andhra Pradesh, India, 500012
Actively Recruiting
64
Nizams Institute of Medical Sciences
Hyderabad, Andhra Pradesh, India, 500082
Actively Recruiting
65
M.S. Ramaiah Medical College and Hospital
Bangalore, Karnataka, India, 560054
Actively Recruiting
66
Noble Hospital
Pune, Maharashtra, India, 411013
Actively Recruiting
67
Max Super Speciality Hospital - Saket
New Delhi, National Capital Territory of Delhi, India, 110017
Actively Recruiting
68
Sir Ganga Ram Hospital
New Delhi, National Capital Territory of Delhi, India, 110060
Actively Recruiting
69
Regency Health Super Specialty Hospital - Lucknow
Lucknow, Uttar Pradesh, India, 226022
Actively Recruiting
70
Galaxy Hospital - Varanasi
Varanasi, Uttar Pradesh, India, 221010
Actively Recruiting
71
Postgraduate Institute of Medical Education & Research (PGIMER)
Chandigarh, India, 160012
Actively Recruiting
72
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chia-shi, Chiba, Japan, 260-8712
Actively Recruiting
73
Juntendo University Urayasu Hospital
Urayasu-Shi, Chiba, Japan, 279-0021
Actively Recruiting
74
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan, 060-8648
Actively Recruiting
75
Kagawa University Hospital
Kita-Gun Uchiko-Cho, Kagawa-ken, Japan, 761-0793
Actively Recruiting
76
The Kitasato Institute Kitasato University Hospital
Sagamihara-Shi Minami-Ku, Kanagawa, Japan, 252-0375
Actively Recruiting
77
Yokohama City University Hospital
Yokohama, Kanagawa, Japan, 236-0004
Actively Recruiting
78
University of Miyazaki Hospital
Miyazaki, Miyazaki, Japan, 889-1692
Actively Recruiting
79
Niigata University Medical ＆ Dental Hospital
Niigata, Niigata, Japan, 951-8520
Actively Recruiting
80
Social Medical Corporation Yuuaikai Yuuai Medical Center
Tomigusuku-Shi, Okinawa, Japan, 901-0224
Actively Recruiting
81
Saitama Medical University Hospital
Iruma-Gun Moroyama-Machi, Saitama, Japan, 350-0451
Actively Recruiting
82
Japanese Red Cross Musashino Hospital
Musashino-shi, Tokyo, Japan, 180-8610
Actively Recruiting
83
Hospital Raja Permaisuri Bainun
Perak, Pahang, Malaysia, 30450
Actively Recruiting
84
Hospital Canselor Tuanku Muhriz UKM
Cheras, WilayahPersekutuan KualaLumpur, Malaysia, 56000
Actively Recruiting
85
Prince Court Medical Centre
Kuala Lumpur, Malaysia, 50450
Actively Recruiting
86
Ajou University Hospital
Suwon, Gyeonggido, South Korea, 16499
Actively Recruiting
87
Seoul National University Hospital
Seoul, Seoul Teugbyeolsi, South Korea, 3080
Actively Recruiting
88
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
89
Hanyang University Seoul Hospital
Seoul, South Korea, 4763
Actively Recruiting
90
Chung-Ang University Hospital
Seoul, South Korea, 6973
Actively Recruiting
91
Hualien Tzu Chi Hospital
Hualien City, Hualien, Taiwan, 970
Actively Recruiting
92
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Actively Recruiting
93
Kaohsiung Chang Gung Memorial Hospital
Kaohsiung City, Taiwan, 83301
Actively Recruiting
94
China Medical University Hospital
Taichung, Taiwan, 40447
Actively Recruiting
95
Taichung Veterans General Hospital
Taichung, Taiwan, 40705
Actively Recruiting
96
National Cheng Kung University Hospital
Tainan, Taiwan, 70403
Actively Recruiting
97
MacKay Memorial Hospital
Taipei, Taiwan, 104
Actively Recruiting
98
Taipei Medical University Hospital - PPDS
Taipei, Taiwan, 11031
Actively Recruiting
99
Taipei Municipal Wanfang Hospital
Taipei, Taiwan, 116
Actively Recruiting
100
Chang Gung Memorial Hospital
Taoyuan, Taiwan, 33305
Actively Recruiting
Research Team
U
US Biogen Clinical Trial Center
G
Global Biogen Clinical Trial Center
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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