Mezagitamab Compared to Placebo as Add-on to Stable Background Therapy to Treat IgA Nephropathy
Research type
Research Study
Full title
A Phase 3 Multicenter, Randomized, Double-Blind, Placebo Controlled Trial to Evaluate Efficacy and Safety of Mezagitamab (TAK-079) in Study Participants with Primary IgA Nephropathy in Combination with Stable Background Therapy
IRAS ID
1012208
Contact name
Parth Patwari
Contact email
Sponsor organisation
Takeda Development Center Americas, Inc
Clinicaltrials.gov Identifier
Research summary
Immunoglobulin A nephropathy (IgAN) is a kidney condition. It happens when the immune system creates groups of proteins that build-up in the kidneys causing swelling. This may lead to kidney damage. Many people with IgAN have too much protein in their urine. Currently, there are only a few effective treatment options for IgAN. Mezagitamab is a potential new medicine to treat IgAN. Researchers will check how well mezagitamab works and how safe it is compared to a placebo. The placebo looks just like the mezagitamab but does not have any medicine in it. Using a placebo helps researchers learn about the real effects of the treatment
This study, sponsored by Takeda Development Center Americas Inc, has a main group and the open-label group. The main group will be double blinded. This means that neither the participants nor the study doctors will know if they are receiving mezagitamab or placebo. Participants will be placed in the groups by chance in a 2:1 ratio (out of 3 participants, 2 mezagitamab and 1 placebo).
In the open-label group, all participants will receive mezagitamab.
Every participant will receive mezagitamab as 2 injections under the skin.
Participants will be in the study for 2 years ; two 1-year treatment periods. In each period, participants will first receive study medicine for 22 weeks and will then be observed monthly for another 30 weeks. Participants will have about 40 visits to the hospital and have blood and urine tests, ECG, vital sign and physical examinations.
The study will include 347 adults at hospitals in the UK and worldwide who have been diagnosed with IgAn for 10 years and are already receiving medicines to manage blood pressure and protein in the urine. 297 in the main group and 50 in the open label. Every participant in this study will be able to stay on most of their current IgAN medications.
Patients cannot take part if they have other kidney problems not caused by IgAN or had/will have an organ transplant.REC name
London - London Bridge Research Ethics Committee
REC reference
25/LO/0499
Date of REC Opinion
18 Jul 2025
REC opinion
Further Information Favourable Opinion