A study to evaluate efficacy and safety of telitacicept in the treatment of patients with primary IgA nephropathy at high risk of progression.
IgA nephropathy is a glomerulonephritis characterized by pathological IgA deposition in the mesangial region. Its clinical and pathological manifestations are diverse and heterogeneous. Its pathogenesis has not yet been fully clarified, and there is currently no unified treatment plan. As a recombinant human B lymphocyte stimulator receptor-antibody fusion protein, telitacicept has become a new therapeutic target. The results of the Phase II clinical trial of this drug for IgA nephropathy have already been published. It is one of the key pioneering clinical studies in the field of IgA nephropathy treatment. The study showed that telitacicept can effectively reduce patients' proteinuria and reduce the risk of disease progression. Based on the above research results, the investigators plan to conduct a multicenter, randomized, controlled clinical study to evaluate the efficacy and safety of telitacicept in the treatment of primary IgA nephropathy patients with a high risk of progression.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
118
Patients in telitacicept group will be treated with maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and/or angiotensin II receptor blocker ( ARB ) combined with telitacicept. 240 mg telitacicept will be used once a week for 40 weeks.
Patients in glucocorticoid group will be treated with ACEI/ARB and glucocorticoid ( prednisone/prednisolone) 0.5mg/kg (maximum 40mg/d). After 8 weeks, reduce the dosage by 5 mg per month for a total of 28-40 weeks.
Ruijin Hospital
Shanghai, China
RECRUITINGChange of 24-hour urine protein
Change of 24-hour urine protein from baseline to week 40
Time frame: From baseline to week 40
Change of PCR
Change of 24-hour urine protein creatinine ratio (PCR) from baseline to week 40
Time frame: From baseline to week 40
Annualized eGFR slope
Annualized eGFR slope from baseline to week 40
Time frame: From baseline to week 40
Change of eGFR
Change of eGFR from baseline to week 40
Time frame: From baseline to week 40
Proportion of patients with a decrease in eGFR ≥30%
Proportion of patients with a decrease in eGFR ≥30% from baseline to week 40
Time frame: From baseline to week 40
Proportion of patients with a decrease in eGFR ≥40%
Proportion of patients with a decrease in eGFR ≥40% from baseline to week 40
Time frame: From baseline to week 40
Change of 24-hour urine ACR
Change of 24-hour urine albumin creatinine ratio (ACR) from baseline to week 40
Time frame: From baseline to week 40
Proportion of patients achieving 24-hour urine PCR < 0.6 g/g
Proportion of patients achieving 24-hour urine PCR \< 0.6 g/g from baseline to week 40
Time frame: From baseline to week 40
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Time from the first use of treatment to the occurrence of a composite endpoint event
Time from the first use of treatment to the occurrence of a composite endpoint event. The composite endpoint event was defined as: the time from the first use of treatment to the first decrease in eGFR from baseline by ≥30% or ≥40% (at least 4 weeks), initiation of maintenance renal dialysis (at least 4 weeks), eGFR \<15 mL/min/1.73m2 (at least 4 weeks), renal transplantation, or death due to renal failure.
Time frame: Up to 40 weeks