Investigating an additional treatment for IgA nephropathy
This phase III study investigates mezagitamab as an additional treatment for primary IgA nephropathy. This page provides available information about the study design and participating centres.
NEFRO-NL • Study portfolio for professionals
Mezagitamab for primary IgA nephropathy
Study summary
This randomized, double-blind phase III trial evaluates whether mezagitamab, a fully human anti-CD38 IgG1 monoclonal antibody targeting plasma cells, reduces proteinuria in primary IgA nephropathy (IgAN) compared with placebo on top of stable standard-of-care therapy.
Which patients may be eligible?
Key inclusion criteria
- Primary IgAN confirmed by kidney biopsy within the past 10 years
- Urine protein-to-creatinine ratio (UPCR) ≥1 g/g or proteinuria ≥1 g/day
- Stable, maximally tolerated RAS inhibition for at least 12 weeks
- eGFR >30 mL/min/1.73 m²
Key exclusion criteria
- Secondary IgAN (e.g., associated with inflammatory bowel disease)
- Rapidly progressive glomerulonephritis
- Nephrotic syndrome
- Kidney or other solid organ transplantation
- Immunosuppressive therapy within the past 6 months
Eligibility is assessed exclusively by the treating physician or study team.
About this study
Study aim
To evaluate the effect of mezagitamab compared with placebo on proteinuria in patients with primary IgA nephropathy.
Intervention / treatment
Mezagitamab
Study design
Phase III – randomised, double-blind, placebo-controlled
Trial duration per participant
104 weeks
Participating centres
Radboud UMC
Relevant links
Contact NEFRO-NL
How can we help you?
Would you like to learn more about NEFRO-NL, our research network or our services? Our project managers are happy to help. Contact us at info@nefro-nl.nl.
Antina de Boer
Project Manager
