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.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 454 (estimated) |
| Sponsor | Biogen Industry-sponsored |
| Drugs / interventions | rituximab, infliximab, eculizumab, canakinumab, cyclophosphamide, prednisone, felzartamab |
| Locations | 265 sites (Little Rock, Arkansas and 264 other locations) |
| Status | Recruiting |
| Started | May 8, 2025 |
| Main results expected | May 31, 2027 |
| Study ends | June 5, 2029 |
| Registry record updated | October 14, 2026 |
| Trial ID | NCT06935357 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
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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
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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
- Study coordinator: US Biogen Clinical Trial Center
- Email: clinicaltrials@biogen.com
- Phone: 866-633-4636
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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How ARGX-121 affects protein in IgA nephropathy
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-
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ADX-038 with or without telitacicept for Chinese adults with IgA nephropathy, C3G, or IC-MPGN
This Phase 2 trial will test whether ADX-038, given alone or with telitacicept, is safe and helps Chinese adults with biopsy-confirmed IgA nephropathy, complement 3 glomerulopathy, or immune complex MPGN.
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Felzartamab infusions for adults with kidney transplants and late isolated microvascular inflammation
This study will try felzartamab infusions in adults with kidney transplants who developed late isolated microvascular inflammation to see if the inflammation goes away after 24 weeks.
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Zigakibart treatment for IgA nephropathy
This trial will test whether the drug zigakibart can slow disease progression in people with biopsy-confirmed IgA nephropathy and persistent proteinuria.
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Felzartamab infusions for adults with primary membranous nephropathy
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.