RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Felzartamab for Primary Membranous Nephropathy

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.

Official registry: https://clinicaltrials.gov/study/NCT06962800 · Biogen · enrollment listed as 180

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Felzartamab, Tacrolimus, or Standard of Care IST. The registry lists allocation as randomized. In this study, researchers will learn more about the use of felzartamab in participants with primary membranous nephropathy, also known as PMN.

They plan to enroll about 180 people at 117 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Felzartamab, Tacrolimus, Standard of Care IST

Primary outcome (registry wording): Percentage of Participants who Achieve Complete Remission (CR) at Week 104

Who it is for (from inclusion criteria)

Ages 18 Years to 80 Years
Meets one of the following:
Newly diagnosed PMN, defined as having never received IST for PMN in the past
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

Who the registry excludes

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/

Public study contact (from the registry)

US Biogen Clinical Trial Center

866-633-4636

clinicaltrials@biogen.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

117 listed

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)

+ 101 sites outside the US on the same record

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FAQ about this NCT record

Is NCT06962800 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT06962800?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT06962800?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary