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Felzartamab infusions for adults with primary membranous nephropathy

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

Phase 3 Interventional Biogen · NCT06962800

This study tests whether felzartamab infusions help adults with primary membranous nephropathy reach complete remission of proteinuria compared with tacrolimus.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment180 (estimated)
Ages18 Years to 80 Years
SexAll
SponsorBiogen Industry-sponsored
Drugs / interventionsfelzartamab
Locations93 sites (Huntsville, Alabama and 92 other locations)
Trial IDNCT06962800 on ClinicalTrials.gov

What this trial studies

In this Phase 3, randomized interventional trial, adults with primary membranous nephropathy and nephrotic-range proteinuria will receive either felzartamab infusions or tacrolimus alongside standard-of-care immunosuppression. The primary endpoint is the rate of complete remission of proteinuria, with secondary endpoints including additional clinical remission measures, changes in serum anti-PLA2R antibody levels, patient-reported outcomes, and safety, pharmacokinetics, and immunogenicity. Diagnosis must be confirmed by kidney biopsy or positive anti-PLA2R antibody testing according to protocol requirements. Participants will be followed at multiple timepoints to compare efficacy and adverse events between treatment arms.

Who should consider this trial

Good fit: Adults with biopsy-confirmed primary membranous nephropathy or anti-PLA2R–positive PMN who require immunosuppressive therapy and have nephrotic-range proteinuria are the intended participants.

Not a fit: Patients with secondary membranous nephropathy, non–antibody-mediated disease, advanced irreversible kidney failure, or contraindications to immunosuppression may not receive benefit from felzartamab.

Why it matters

Potential benefit: If successful, felzartamab could increase rates of complete remission of proteinuria and reduce progression to kidney failure for people with PMN.

How similar studies have performed: B-cell–targeting therapies such as rituximab have shown benefit in PMN, but felzartamab represents a newer plasma cell–targeting approach with more limited prior clinical data in this disease.

Eligibility criteria

Show full inclusion / exclusion 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 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.

Key Exclusion Criteria:

* Secondary cause of MN (e.g., malignancies, medications, systemic lupus erythematosus \[SLE\], hepatitis B, hepatitis C, etc).
* 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.

Note: Other protocol-defined Inclusion/Exclusion criteria may apply.

Where this trial is running

Huntsville, Alabama and 92 other locations

+43 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Primary Membranous Nephropathy
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.