A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)
NCT ID: NCT06962800
Last Updated: 2026-02-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
180 participants
INTERVENTIONAL
2025-05-22
2029-03-29
Brief Summary
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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.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Open-Label Treatment Phase
Participants will receive several intravenous (IV) doses of felzartamab or oral tacrolimus in the Open-Label Treatment Phase.
Felzartamab
Administered intravenously
Tacrolimus
Administered orally
Non-Responder Treatment Phase
Participants 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.
Felzartamab
Administered intravenously
Standard of Care IST
Administered intravenously and orally
Interventions
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Felzartamab
Administered intravenously
Tacrolimus
Administered orally
Standard of Care IST
Administered intravenously and orally
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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:
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 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.
Exclusion Criteria
* 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.
18 Years
80 Years
ALL
No
Sponsors
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Biogen
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Biogen
Locations
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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
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
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Nephrotex Research Group
Dallas, Texas, United States
University of Texas Medical Branch
League City, Texas, 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
Westmead Hospital
Westmead, New South Wales, Australia
Townsville Hospital
Douglas, Queensland, Australia
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
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
Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, , Brazil
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
Gansu Provincial Hospital
Lanzhou, Gansu, China
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, 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
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Yueyang People Hospital
Yueyang, Hunan, China
Qilu Hospital of Shandong University
Jinan, Shandong, China
National Hospital Organization Chiba Medical Center Chibahigashi National Hospital
Chia-shi, Chiba, Japan
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan
Kagawa University Hospital
Kita-Gun Uchiko-Cho, Kagawa-ken, 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
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
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
Kaohsiung Medical University Chung-Ho 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
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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2024-519232-16-00
Identifier Type: OTHER
Identifier Source: secondary_id
299PN301
Identifier Type: -
Identifier Source: org_study_id
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