A Phase 1b Study of Mezagitamab (TAK-079) in patients with primary IgA Nephropathy
Research type
Research Study
Full title
A Phase 1b, Multicenter, Open-Label Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Efficacy of Mezagitamab (TAK-079) in Patients With Primary IgA Nephropathy in Combination With Stable Background Therapy
IRAS ID
1005748
Contact name
Tanya Manor
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc
Eudract number
2021-005023-20
Clinicaltrials.gov Identifier
Research summary
Immunoglobulin A (IgA) nephropathy is a rare condition that causes inflammation (swelling) and kidney damage due to build-up of an antibody called IgA in kidney. This inflammation is a rare, serious condition that can lead to chronic kidney disease (CKD) and, eventually, to end-stage kidney disease (ESKD). Currently, effective therapeutic options for IgAN are limited. Studies suggest that despite administration of maximal doses, these agents have failed to lower the amount of protein kidney leaks out.
Administration of mezagitamab to patients with IgAN is anticipated to restore ameliorate disease progression by acting at the source of the pathogenesis of IgAN through reduction of plasma cells responsible for the production of abnormal protein called gd-IgA1. It is anticipated that, over time, a reduction in the formation of pathogenic immune complexes will prevent further kidney injury and promote stabilisation of kidney function, suggesting a potential opportunity for mezagitamab to improve long-term renal outcomes in patients with IgAN.
This is a Phase 1b, Multicenter, Open-Label Study to test the safety and effectiveness of the study drug, mezagitamab, in adults with IgAN, currently on their usual medication for IgAN, also known as stable background IgAN therapy.
The maximum duration of participation in the study will be approximately 154 weeks.
Patients who had a favourable proteinuric response to mezagitamab treatment by Week 48 of the main study can enter the Long-term Extension (LTE) study. the LTE study consists of an observation period and a retreatment period. The retreatment period is part of the overall LTE study, but only patients who meet retreatment eligibility may enter this period.REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
22/NE/0137
Date of REC Opinion
23 Sep 2022
REC opinion
Further Information Favourable Opinion