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

IgAN is Primary Immunoglobulin A Nephropathy (IgAN) (also known as Berger's disease)

Change from baseline in proteinuria at Week 36 as assessed by a UPCR calculated from a 24-hour urine collection.

01. The change from baseline in eGFR at Week 52., 02. The rate of change in eGFR from baseline to Week 52; eGFR total slope at Week 52., 03. The change from baseline in eGFR at Week 104., 04. The rate of change in eGFR from baseline to Week 104; eGFR total slope at Week 104., 05. Time from baseline to the first occurrence of sustained decline in eGFR of ≥30% from baseline over at least 4 weeks., 06. Time from baseline to the first occurrence of any of the following outcomes based on the kidney failure composite endpoint: sustained decline in eGFR of ≥30% from baseline over at least 4 weeks; sustained eGFR <15 mL/min/1.73 m2 over at least 4 weeks; initiation of maintenance dialysis defined as dialysis performed for at least 4 weeks; receipt of kidney transplant; or death from kidney failure (Levin et al. 2020)., 07. Change from baseline in proteinuria levels as assessed by UPCR calculated from a 24-hour urine collection at Week 104., 08. Resolution of hematuria at Week 36., 09. Resolution of hematuria at Week 52., 10. Resolution of hematuria at Week 104, 11. Incidence of ADA., 12. Incidence of NAb., 13. The serum concentrations of mezagitamab during and after intervention.

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