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A Study of Felzartamab for Primary Membranous Nephropathy (PMN)

This study is looking into how safe and effective felzartamab infusions are for adults with Primary Membranous Nephropathy (PMN). PMN is a kidney disease where the body's own immune system mistakenly attacks the filters in your kidneys (glomeruli), causing damage and leading to too much protein in your urine. Researchers will compare felzartamab to tacrolimus and standard care treatments. We want to see if felzartamab can help people achieve complete remission, meaning a significant reduction in protein in their urine. You may be able to join if you are between 18 and 80 years old, have been diagnosed with PMN, and your doctor thinks you need treatment. The study plans to enroll about 180 participants, but its current status is unclear.

Study design
This interventional study plans to enroll about 180 participants to compare felzartamab with tacrolimus and standard care treatments.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
The main goal of the study is measured at Week 104, suggesting follow-up for at least that long.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06962800

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

Recruiting
PHASE3Ages 18–80InterventionalTreatment
Biogen
~180 participants
Updated 2026-08-26 on ClinicalTrials.gov
What's tested:FelzartamabTacrolimusStandard of Care IST

At a glance

Recruiting sites
111 of 112 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants who Achieve Complete Remission (CR) at Week 104
Measured over Week 104

Conditions

Primary Membranous Nephropathy

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Where it's being run

112 sites across 60 states
Taiwan9
California5
Argentina5
New South Wales4
Queensland4
Shandong4
Guangdong3
Zhejiang3

Study leadership

  • Medical Director · STUDY_DIRECTOR · Biogen

Who to contact

US Biogen Clinical Trial Center
[email protected]
866-633-4636
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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.
Meets one of the following:
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.

Exclusion

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.

What this trial measures

  • Percentage of Participants who Achieve Complete Remission (CR) at Week 104Week 104