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.
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IgA nephropathy was confirmed by pathological biopsy.
Age range: ≥ 18 years old, ≤ 70 years old, male or female.
During the screening period, the 24-hour urine protein of Visit 1 and Visit 2 should meet at least one ≥0.75g/24h, and the 24-hour urine protein ≥ 0.75g/24h at Visit 3.
Abnormal laboratory indicators of participants need to be excluded.
Secondary IgA nephropathy need to be excluded.
Specific pathologic or clinical renal disease types, and IgA nephropathy that may require hormone therapy.
Patients who have experienced any of the following cardiovascular and cerebrovascular events within the 12 weeks prior to screening.
Single group
Telitacicept
DrugTelitacicept will be subcutaneously injected at a dose of 240mg per week, lasting for 104 weeks.
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.
The absolute value of eGFR
The absolute value of eGFR decreased by more than 15 ml/min/1.73m2 over 3 years from baseline
Changes in 24-hour urinary protein
Changes in 24-hour urinary protein at week 104 compared with baseline.
eGFR decrease
The estimated glomerular filtration rate (eGFR) decreased by more than 30 ml/min/1.73 m2 from baseline.
Need for dialysis
progression to end-stage renal disease
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This trial is not recruiting at the moment. You can still explore other options:
