A Multicenter, Randomized, Controlled Study on the Efficacy and Safety of Telitacicept Compared to Glucocorticoids in Patients with Primary IgA Nephropathy

What this Trial Is About

Researchers are evaluating the efficacy and safety of telitacicept in treating patients with primary IgA nephropathy who are at high risk of disease progression. IgA nephropathy is a kidney condition characterized by the buildup of IgA protein deposits in kidney tissues, leading to diverse symptoms and outcomes. Current treatments are not unified, and telitacicept, a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, is being studied due to its potential to reduce proteinuria and slow disease progression, as shown in previous Phase II trials. The study compares two treatment groups: one receiving telitacicept 240 mg once a week for 40 weeks along with the maximum tolerable dose of angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin II receptor blockers (ARB), and the other receiving glucocorticoids (prednisone/prednisolone) combined with ACEI/ARB. Glucocorticoid doses start at 0.5 mg/kg (up to 40 mg daily) and are tapered after 8 weeks over a total treatment period of 28 to 40 weeks. Both groups continue their standard ACEI/ARB therapy throughout the study. Participants will be monitored for changes in 24-hour urine protein from baseline to week 40, which is the primary outcome measure. During the study, patients will undergo regular assessments to evaluate kidney function and protein levels in urine. Safety and efficacy data will be collected throughout the treatment period, and participants will be followed closely by study staff to ensure adherence and monitor for any side effects or complications related to the study treatments.

Efficacy and Safety of Telitacicept in IgAN