Open-label Study Evaluating Zigakibart Injections Over Two Years for Adults with Immunoglobulin A Nephropathy

What this Trial Is About

Researchers are evaluating the effects of the drug zigakibart on the progression of Immunoglobulin A Nephropathy IgAN, a kidney disease. This open-label, multicenter study will randomize participants into two groups that differ only by the timing of an on-treatment kidney biopsy, either at the end of the first or second year of treatment. The study aims to understand how zigakibart influences disease markers over time. Participants will receive subcutaneous injections of zigakibart at a dose of 600 mg every two weeks for up to two years 104 weeks. The study includes a maximum screening period of 8 weeks, followed by the 104-week treatment period, and concludes with a 13-week safety follow-up. The two groups differ in the timing of kidney biopsies taken to assess treatment effects either at week 53 or week 105. During the study, participants will undergo various assessments including measurement of kidney function, protein levels in urine, and immune markers such as mesangial IgA deposition and complement components. Safety will be monitored through tracking of adverse events throughout treatment and follow-up. Blood samples will be collected at multiple time points to measure drug levels and antibodies against the drug. The total participation time can be up to approximately 125 weeks.

A Study to Assess the Effects of Zigakibart on IgA Nephropathy.