Clinical trial Recruiting at 251 sites Phase 3 Interventional Ages 18 and up

Effects of Felzartamab on Adults with Immunoglobulin A Nephropathy

Official title: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Felzartamab in Adults With IgA Nephropathy (PREVAIL)

Run by Biogen · NCT06935357 · Data updated 2026-11-12

This study is testing if felzartamab infusions can help adults with immunoglobulin A nephropathy reduce protein in their urine and improve kidney function.

More IgA Nephropathy (IgAN) trials

Quick facts

PhasePhase 3
Study typeInterventional
Ages18 Years and up
SexAll
Enrollment454 (estimated)
SponsorBiogen
Industry-sponsored
Drugs / interventionsrituximab, infliximab, eculizumab, canakinumab, cyclophosphamide, prednisone, felzartamab
Locations265 sites (Little Rock, Arkansas and 264 other locations)
StatusRecruiting
StartedMay 8, 2025
Main results expectedMay 31, 2027
Study endsJune 5, 2029
Registry record updatedOctober 14, 2026
Trial IDNCT06935357 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include adults with a biopsy-confirmed diagnosis of IgAN and significant proteinuria.

Probably not a fit

Patients with eGFR below 20 mL/min/1.73m² or those without proteinuria may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the impact of felzartamab infusions on adults diagnosed with immunoglobulin A nephropathy (IgAN), specifically focusing on participants with proteinuria due to kidney damage. Participants will be randomly assigned to receive either felzartamab or a placebo, with neither the researchers nor participants aware of which treatment is being administered. The primary goal is to assess changes in protein levels in urine over 36 weeks, while also evaluating kidney function and the safety of the treatment. The study aims to provide insights into how felzartamab is processed by the body and its overall efficacy in managing IgAN.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce proteinuria and improve kidney function in patients with IgAN.

How similar studies have gone: Previous studies have shown promise with similar treatments, but this specific approach with felzartamab is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Key Inclusion Criteria:

* Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, an IgAN diagnostic biopsy within the past 24 months prior to signing the ICF.
* An eGFR ≥ 30 mL/min/1.73 m\^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and \< 30 mL/min/1.73 m\^2 is acceptable for the cohorts 3 and 4.
* Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.
* Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is); endothelin receptor antagonists (ERAs) or dual endothelin angiotensin receptor antagonist (DEARAs) approved for the treatment of IgAN; and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using a DEARA (e.g., sparsentan) will not be permitted to use simultaneous ACEI or ARB medication.

Key Exclusion Criteria:

* Any history of secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.
* History of rapidly progressive variant of IgAN, defined as eGFR loss by \> 50% per 3 months and not explained by changes in renin-angiotensin system (RAS) blockade or other factors.
* IgAN-(MCD) variant.
* Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
* Type 2 diabetes mellitus with Hemoglobin A1c (HbA1c) \> 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).
* Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, human immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.
* Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, mycophenolate mofetil (MMF) or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic glucocorticoid exposure (\> 7.5 milligrams per day \[mg/d\] prednisone-equivalent for indications other than IgAN or any dose if given for the treatment of IgAN) within 4 months prior to Screening. Use of hydroxychloroquine in Mainland China is allowed if the candidate has been on this for at least 6 months prior to Screening with a stable dose for at least 12 weeks prior to Screening. If a potential participant requires systemic glucocorticoids at any dose for IgAN during Screening, this will result in a screen fail. If a potential participant requires systemic glucocorticoids \> 7.5 mg/day prednisone-equivalent for indications other than IgAN during Screening, this will result in a screen fail.
* Participants currently treated with oral budesonide. Participants who have stopped this therapy ≥ 4 months prior to Screening may be eligible.
* Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or non-prophylactic treatment with IV anti-infectives (antibacterials, antiviral or antifungals). Participants with a history of opportunistic infections are excluded.
* Hypogammaglobulinemia: serum Immunoglobin G (IgG) \< 6.0 gram per litre (g/L), at Screening.

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

Where it's running

  • Applied Research Center of Arkansas
    Little Rock, Arkansas, United States
    Recruiting
  • Kidney & Hypertension Center - Apple Valley
    Apple Valley, California, United States
    Recruiting
  • Scripps Green Hospital
    Carlsbad, California, United States
    Recruiting
  • UCLA Health David Geffen School of Medicine
    Los Angeles, California, United States
    Recruiting
  • FOMAT Medical Research - FOMAT - PPDS
    Oxnard, California, United States
    Recruiting
  • North America Research Institute-San Dimas
    San Dimas, California, United States
    Recruiting
Show 44 more locations
  • Nova Clinical Research, LLC
    Bradenton, Florida, United States
    Recruiting
  • University of Florida - Gainesville - 1600 SW Archer Rd
    Gainesville, Florida, United States
    Recruiting
  • Royal Research, Corp.
    Hollywood, Florida, United States
    Recruiting
  • Central Florida Kidney Specialists
    Orlando, Florida, United States
    Recruiting
  • CDC Research Institute, LLC
    Port Saint Lucie, Florida, United States
    Recruiting
  • The Vasculitis and Glomerulonephritis Center at Massachusetts General Hospital
    Boston, Massachusetts, United States
    Recruiting
  • Brigham and Women's Hospital
    Boston, Massachusetts, United States
    Recruiting
  • UMass Memorial Medical Center
    Worcester, Massachusetts, United States
    Recruiting
  • Henry Ford Hospital
    Detroit, Michigan, United States
    Recruiting
  • Anointed Nephrology and HTN - SKYCRNG - PPDS
    Brookhaven, Mississippi, United States
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York, United States
    Recruiting
  • James J Peters Veterans Administration Medical Center - NAVREF - PPDS
    The Bronx, New York, United States
    Recruiting
  • Lifespan at Rhode Island Hospital
    Providence, Rhode Island, United States
    Recruiting
  • Knoxville Kidney Center, PLLC
    Knoxville, Tennessee, United States
    Recruiting
  • Texas Kidney Institute - Dallas
    Dallas, Texas, United States
    Recruiting
  • Provecta Research Network
    Houston, Texas, United States
    Recruiting
  • R & H Clinical Research
    Katy, Texas, United States
    Recruiting
  • Medical College of Wisconsin, Inc.
    Milwaukee, Wisconsin, United States
    Recruiting
  • Hospital General de Agudos Dr. Cosme Argerich
    La Boca, Buenos Aires F.D., Argentina
    Recruiting
  • Hospital Italiano de Buenos Aires
    Almagro, Ciudad Autónoma de BuenosAires, Argentina
    Recruiting
  • INECO Neurociencias Oroño
    Rosario, Santa Fe Province, Argentina
    Recruiting
  • CIMER-Centro Integral de Medicina Respiratoria
    San Miguel de Tucumán, Tucumán Province, Argentina
    Recruiting
  • Consultorios Médicos Dr. Doreski - Fundacion Respirar - PPDS
    Buenos Aires, Argentina
    Recruiting
  • DOM Centro de Reumatología
    Buenos Aires, Argentina
    Recruiting
  • Clínica de Nefrología Urología Y Enfermedades Cardiovasculares
    Santa Fe, Argentina
    Recruiting
  • John Hunter Hospital
    New Lambton, New South Wales, Australia
    Recruiting
  • Concord Repatriation General Hospital
    New South Wales, New South Wales, Australia
    Recruiting
  • Royal North Shore Hospital-Reserve Road
    St Leonards, New South Wales, Australia
    Recruiting
  • Westmead Hospital
    Westmead, New South Wales, Australia
    Recruiting
  • Townsville Hospital
    Douglas, Queensland, Australia
    Recruiting
  • Royal Brisbane & Women's Hospital
    Herston, Queensland, Australia
    Recruiting
  • Gold Coast University Hospital
    Southport, Queensland, Australia
    Recruiting
  • Griffith University
    Southport, Queensland, Australia
    Recruiting
  • Princess Alexandra Hospital
    Woolloongabba, Queensland, Australia
    Recruiting
  • Sunshine Hospital - Australia
    St Albans, Victoria, Australia
    Recruiting
  • Hôpital Erasme - PPDS
    Anderlecht, Brussels Capital, Belgium
    Recruiting
  • UZ Leuven - PPDS
    Leuven, Vlaams Brabant, Belgium
    Recruiting
  • Jan Yperman
    Ieper, West-Vlaanderen, Belgium
    Recruiting
  • AZ Groeninge
    Kortrijk, West-Vlaanderen, Belgium
    Recruiting
  • Cliniques Universitaires Saint-Luc
    Brussels, Belgium
    Recruiting
  • Freire Pesquisa Clínica
    Belo Horizonte, Minas Gerais, Brazil
    Recruiting
  • Irmandade da Santa Casa de Misericórdia de Belo Horizonte - PPDS
    Belo Horizonte, Minas Gerais, Brazil
    Recruiting
  • Centro Mineiro de Pesquisa - CMiP
    Juiz de Fora, Minas Gerais, Brazil
    Recruiting
  • Fundação Universidade de Caxias do Sul - Instituto de Pesquisas em Saúde
    Caxias do Sul, Rio Grande do Sul, Brazil
    Recruiting

+215 more sites. See ClinicalTrials.gov for the full list.

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 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.