To evaluate the safety and efficacy of Tai Ai(Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection) in the treatment of IgA nephropathy.
Both RC18 and Recombinant Human B Lymphocyte Stimulator Receptor-Antibody Fusion Protein for Injection are other names of Tai Ai. After a 35-day screen period, subjects are randomly allocated into 3 groups receiving subcutaneous injection of Tai Ai 160mg, Tai Ai 240mg, and placebo once a week individually. The treatment lasts 24 weeks. Subjects, the sponsor, investigators are blinded in the whole process of the trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
44
subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
subcutaneous injection on the upper arm, abdomen, or upper thigh outside;
Peking University First Hospital.
Beijing, Beijing Municipality, China
Change from baseline in 24-hour urine protein excretion at Week 24;
based on the 24 -hour urine collection
Time frame: week 24
Change from baseline in estimated Glomerular Filtration Rate(eGFR)
eGFR is calculated using the CKD-EPI method.
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in urine protein/creatine ratio(UPCR) and/or urine albumin/ creatine ratio(UACR)
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in Immunoglobulin G(IgG);
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in Immunoglobulin M(IgM);
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in Immunoglobulin A(IgA);
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in the count of urine red blood cells
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in the count of B-lymphocytes (CD19+)
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in complement 3(C3)
Time frame: week 0, 4, 8, 12, 16, 20, 24
Change from baseline in complement 4 (C4)
Time frame: week 0, 4, 8, 12, 16, 20, 24
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The incidence rate and severity of adverse events.
An adverse event is any undesirable experience associated with the use of a medical product in a patient.
Time frame: week 0, 4, 8, 12, 16, 20, 24