NCT06962800From ClinicalTrials.govRecruiting

A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)

An Open-Label, Multicenter, Randomized Phase 3 Study Evaluating the Efficacy and Safety of Felzartamab in Participants With Primary Membranous Nephropathy (PMN) [PROMINENT]

Primary Membranous Nephropathy

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Biogen
Enrolment target: 180
Started: 22 May 2025
Main results due: 28 January 2030
Study sites: 114
Registry updated: 29 September 2026

Can you take part?

Ages 18 years to 80 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria

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.

What this study is about

In the sponsor’s own words, from the registry.

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.

Study sites(114)

Apogee Clinical Research, LLC
Huntsville, Alabama, United States
Recruiting
The Nephrology Group, Inc. - Fresno
Fresno, California, United States
Recruiting
Academic Medical Research Institute
Los Angeles, California, United States
Recruiting
UCLA Health Connie Frank Kidney Transplant Center and General Nephrology
Los Angeles, California, United States
Recruiting
UCSF Medical Center
San Francisco, California, United States
Recruiting
Stanford University
Stanford, California, United States
Recruiting
Henry Ford Hospital- A-Basement Research Pharmacy
Detroit, Michigan, United States
Recruiting
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS
Pontiac, Michigan, United States
Completed
James J Peters Veterans Administration Medical Center - NAVREF - PPDS
The Bronx, New York, United States
Recruiting
ECU Physicians Nephrology and Hypertension
Greenville, North Carolina, United States
Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Recruiting
Knoxville Kidney Center, PLLC
Knoxville, Tennessee, United States
Recruiting
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Recruiting
Nephrotex Research Group
Dallas, Texas, United States
Recruiting
University of Texas Medical Branch
League City, Texas, United States
Recruiting
University of Wisconsin School of Medicine and Public Health
Madison, Wisconsin, United States
Recruiting
Organización Médica de Investigación
Buenos Aires, Argentina
Recruiting
CINME S.A. - Centro de Investigaciones Metabólicas
Buenos Aires, Argentina
Recruiting
Hospital Italiano de Buenos Aires
Buenos Aires, Argentina
Recruiting
Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada
Buenos Aires, Argentina
Recruiting
Clínica Privada Vélez Sarsfield
Córdoba, Argentina
Recruiting
Concord Hospital
Concord, New South Wales, Australia
Recruiting
St George Hospital
Kogarah, New South Wales, Australia
Recruiting
Liverpool Hospital
Liverpool, New South Wales, Australia
Recruiting
Westmead Hospital
Westmead, New South Wales, Australia
Recruiting
Townsville Hospital
Douglas, Queensland, Australia
Recruiting
Royal Brisbane and Women s Hospital
Herston, Queensland, Australia
Recruiting
Gold Coast University Hospital
Southport, Queensland, Australia
Recruiting
Griffith University Clinical Trial Unit
Southport, Queensland, Australia
Recruiting
Monash Health
Clayton, Victoria, Australia
Recruiting
Sunshine Hospital - Australia
St Albans, Victoria, Australia
Recruiting
Santa Casa de Misericórdia de Belo Horizonte
Belo Horizonte, Minas Gerais, Brazil
Recruiting
Hospital de Clinicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS)
Porto Alegre, Rio Grande do Sul, Brazil
Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo
Ribeirão Preto, São Paulo, Brazil
Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS
São José do Rio Preto, São Paulo, Brazil
Recruiting
Hospital Alemao Oswaldo Cruz (HAOC)
São Paulo, Brazil
Recruiting
Centro de Pesquisa Clínica de Nefrologia do Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo
São Paulo, Brazil
Recruiting
Vancouver Coastal Health Research Institute
Vancouver, British Columbia, Canada
Recruiting
London Health Sciences Centre - Victoria Hospital
London, Ontario, Canada
Recruiting
Fu Yang People's Hospital - South Campus
Fuyang, Anhui, China
Recruiting
Beijing Tsinghua Changgung Hospital
Beijing, Beijing Municipality, China
Recruiting
Peking University First Hospital - Changqiao Campus
Xichengqu Beijing, Beijing Municipality, China
Recruiting
Zhongshan Hospital Xiamen University
Xiamen, Fujian, China
Recruiting
Gansu Provincial Hospital
Lanzhou, Gansu, China
Recruiting
Lanzhou University Second Hospital
Lanzhou, Gansu, China
Recruiting
Zhujiang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Recruiting
Shenzhen Hospital of Southern Medical University
Shenzhen, Guangdong, China
Recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China
Recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Recruiting
The People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, Guangxi, China
Recruiting
The Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou, China
Recruiting
The Second Hospital of Hebei Medical University - Main
Shijiazhuang, Hebei, China
Recruiting
The First Hospital of Hebei Medical University
Shijiazhuang, Hebei, China
Recruiting
Daqing Oilfield General Hospital
Daqing, Heilongjiang, China
Recruiting
The First Affiliated Hospital of Henan Science and Technology University - Jinghua Campus
Luoyang, Henan, China
Recruiting
Yichang Central People's Hospital - Wujiagang Campus
Yichang, Hubei, China
Recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China
Recruiting
Yueyang People Hospital
Yueyang, Hunan, China
Recruiting
The Second Affiliated Hospital of Nanjing Medical University - Main Campus
Nanjing, Jiangsu, China
Recruiting

Showing 60 of 114 sites — filter to narrow it down. 113 of the 114 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06962800. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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