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Effects of Felzartamab on Adults with Immunoglobulin A Nephropathy

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

Phase 3 Interventional Biogen · NCT06935357

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

PhasePhase 3
Study typeInterventional
Enrollment454 (estimated)
Ages18 Years and up
SexAll
SponsorBiogen Industry-sponsored
Drugs / interventionsrituximab, infliximab, eculizumab, canakinumab, cyclophosphamide, prednisone, felzartamab
Locations233 sites (Little Rock, Arkansas and 232 other locations)
Trial IDNCT06935357 on ClinicalTrials.gov

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.

Who should consider this trial

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

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

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

Eligibility criteria

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 this trial is running

Little Rock, Arkansas and 232 other locations

+183 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 Immunoglobulin A NephropathyFelzartamab
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.