🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT06962800
Recruiting Phase 3

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

NCT06962800 · tracked via the Priya Life Science India tracker
Sponsor
Biogen
Phase
Phase 3
Started
2025-05-22
Last updated
2026-08-26

Condition(s) studied

Primary Membranous Nephropathy

Investigational drug(s) / intervention(s)

FelzartamabTacrolimusStandard of Care IST

Felzartamab: Administered intravenously

Tacrolimus: Administered orally

Standard of Care IST: Administered intravenously and orally

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (112)

FacilityCityRegionStatus
Apogee Clinical Research, LLC Huntsville Alabama Recruiting
The Nephrology Group, Inc. - Fresno Fresno California Recruiting
Academic Medical Research Institute Los Angeles California Recruiting
UCLA Health Connie Frank Kidney Transplant Center and General Nephrology Los Angeles California Recruiting
UCSF Medical Center San Francisco California Recruiting
Stanford University Stanford California Recruiting
Henry Ford Hospital- A-Basement Research Pharmacy Detroit Michigan Recruiting
Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS Pontiac Michigan Completed
James J Peters Veterans Administration Medical Center - NAVREF - PPDS The Bronx New York Recruiting
ECU Physicians Nephrology and Hypertension Greenville North Carolina Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio Recruiting
Knoxville Kidney Center, PLLC Knoxville Tennessee Recruiting
Vanderbilt University Medical Center Nashville Tennessee Recruiting
Nephrotex Research Group Dallas Texas Recruiting
University of Texas Medical Branch League City Texas Recruiting
University of Wisconsin School of Medicine and Public Health Madison Wisconsin 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 Recruiting
St George Hospital Kogarah New South Wales Recruiting
Liverpool Hospital Liverpool New South Wales Recruiting
Westmead Hospital Westmead New South Wales Recruiting
Townsville Hospital Douglas Queensland Recruiting
Royal Brisbane and Women s Hospital Herston Queensland Recruiting
Gold Coast University Hospital Southport Queensland Recruiting
Griffith University Clinical Trial Unit Southport Queensland Recruiting
Monash Health Clayton Victoria Recruiting
Sunshine Hospital - Australia St Albans Victoria Recruiting
Santa Casa de Misericórdia de Belo Horizonte Belo Horizonte Minas Gerais Recruiting
Hospital de Clinicas de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Hospital Sao Lucas Da Pontificia Universidade Catolica Do Rio Grande Do Sul (PUCRS) Porto Alegre Rio Grande do Sul Recruiting
Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto da Universidade de Sao Paulo Ribeirão Preto São Paulo Recruiting
Fundacao Faculdade Regional de Medicina de Sao Jose Do Rio Preto Hospital de Base - PPDS São José do Rio Preto São Paulo 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 Recruiting
London Health Sciences Centre - Victoria Hospital London Ontario Recruiting

+ 72 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06962800 on ClinicalTrials.gov ↗ ← All trials in India