Study of Telitacicept Treatment for Adults Aged 18 to 70 with Primary IgA Nephropathy at High Risk of Disease Progression

What this Trial Is About

Researchers are evaluating the safety and effectiveness of telitacicept in treating patients with primary IgA nephropathy who are at high risk of disease progression. IgA nephropathy is a kidney condition caused by abnormal IgA deposits, leading to diverse symptoms and uncertain causes. This study is a multicenter, randomized, controlled clinical trial aiming to build on earlier findings that telitacicept may reduce protein in the urine and slow disease progression. Participants will be randomly assigned to one of two groups one group will receive telitacicept 240 mg once a week combined with a stable dose of angiotensin converting enzyme inhibitors ACEI andor angiotensin II receptor blockers ARB for 40 weeks. The other group will receive glucocorticoids prednisone or prednisolone starting at 0.5 mgkg, up to 40 mg daily, with gradual dose reduction after 8 weeks together with ACEIARB for 28 to 40 weeks. Both groups continue their ACEIARB treatment during the study. During the study, participants will have their 24-hour urine protein levels measured from the start until week 40, along with other kidney function tests such as estimated glomerular filtration rate eGFR and urine protein creatinine ratio PCR. Researchers will also monitor safety and record any changes in kidney function or disease progression. The study will last up to 40 weeks, with follow-up to assess the time until any serious kidney-related events occur.

Efficacy and Safety of Telitacicept in IgAN