The goal of this clinical trial is to explore the effectiveness and safety of Telitacicept in adults with refractory IgA nephropathy. The main questions it aims to answer are: * To evaluate the clinical efficacy of Telitacicept in patients with refractory IgA nephropathy. * To evaluate the safety and adverse reaction of Telitacicept in patients with refractory IgA nephropathy. Participants will be subcutaneously injected with 240mg of Telitacicept once per week. Study subject: After 6 months of sequential treatment with renin-angiotensin system (RAS) blockers or glucocorticoids, patients with pathological biopsy of 0.7≥5 g/24 hours of proteinuria was confirmed as refractory IgA nephropathy.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
40
Telitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Complete clinical response
a. Proteinuria: protein-to-creatinine ratio \<0.2; b. Stable renal function: eGFR decreased by less than 5ml/min/1.73m2 from baseline at the end of the 3-year trial phase.
Time frame: 3-year
The absolute value of eGFR
The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline
Time frame: 3-year
Changes in 24-hour urinary protein
Changes in 24-hour urinary protein at week 104 compared with baseline.
Time frame: 104 weeks
eGFR decrease
The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline.
Time frame: 3-year
Need for dialysis
progression to end-stage renal disease
Time frame: 3-year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.