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NCT06962800 · ClinicalTrials.gov registry record · Phase 3

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

A Phase 3 study of Primary Membranous Nephropathy, sponsored by Biogen.

Recruiting
Registry status
Phase 3
Development phase
180
Enrollment target
20
Study locations

NCT06962800 is a Phase 3 study of Primary Membranous Nephropathy that is actively recruiting participants, run by Biogen. The registered enrollment target is 180 participants, above the 114-participant average among 8 other Primary Membranous Nephropathy trials with a reported enrollment target (58% higher). The trial reports 20 study locations across 10 states.

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The verdict

NCT06962800, a Phase 3 study of Primary Membranous Nephropathy, is actively recruiting participants, sponsored by Biogen.

RECRUITING
Registry status
Phase 3
Development phase
180 participants
Enrollment target
20
Study locations

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

Conditions Studied

Primary Membranous Nephropathy

Interventions

  • DRUG Tacrolimus
  • DRUG Felzartamab
  • DRUG Standard of Care IST

Study Locations (20)

Other

  • Organización Médica de Investigación - Buenos Aires
  • CINME S.A. - Centro de Investigaciones Metabólicas - Buenos Aires
  • Hospital Italiano de Buenos Aires - Buenos Aires
  • Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada - Buenos Aires
  • Clínica Privada Vélez Sarsfield - Córdoba

California

  • The Nephrology Group, Inc. - Fresno - Fresno
  • Academic Medical Research Institute - Los Angeles
  • UCSF Medical Center - San Francisco

New South Wales

  • Concord Hospital - Concord
  • St George Hospital - Kogarah
  • Westmead Hospital - Westmead

Michigan

  • Henry Ford Hospital- A-Basement Research Pharmacy - Detroit
  • Elixia Health - Michigan Kidney Consultants, LLC - Elixia - PPDS - Pontiac

Texas

  • Nephrotex Research Group - Dallas
  • University of Texas Medical Branch - League City

Alabama

  • Apogee Clinical Research, LLC - Huntsville

New York

  • James J Peters Veterans Administration Medical Center - NAVREF - PPDS - The Bronx

North Carolina

  • ECU Physicians Nephrology and Hypertension - Greenville

Trial Details

FieldValue
Enrollment Target 180 participants
Start Date 2025-05-22
Est. Completion 2029-03-29
Phase Phase 3

Sponsor

Biogen

334 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06962800

The ClinicalTrials.gov registry entry for NCT06962800 describes a study currently listed as recruiting, categorized as Phase 3. The registered enrollment target is 180 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 114-participant average among 8 other Primary Membranous Nephropathy trials with a reported enrollment target (58% higher). The listed sponsor is Biogen, which has 334 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Primary Membranous Nephropathy appearing as the primary indexed condition, and to 3 interventions - of which Tacrolimus is the first listed.

NCT06962800 reports 20 study locations spanning 10 distinct geographic areas - top geographies include Other, California, New South Wales.

Frequently Asked Questions

What is clinical trial NCT06962800 about?

NCT06962800 is a clinical study titled "A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN)". 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 ...

What is the current status of trial NCT06962800?

This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 180 participants. The study started on 2025-05-22. Estimated completion is 2029-03-29.

What conditions does trial NCT06962800 study?

This clinical trial studies the following conditions: Primary Membranous Nephropathy.

What interventions are being tested in trial NCT06962800?

The interventions under investigation include: Tacrolimus (DRUG), Felzartamab (DRUG), Standard of Care IST (DRUG).

Who is sponsoring clinical trial NCT06962800?

This trial is sponsored by Biogen, which has 334 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT06962800 being conducted?

This trial has 20 study locations across Alabama, California, Michigan, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.