The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Telitacicept in patients with IgA nephropathy. The control group will be observed for up to 6months without administration of Telitacicept. This Single center, Randomized, Open Label, Comparative study will evaluate the effect and safety of and Standard treatment for 6months in IgA Nephropathy.
IgA nephropathy is the most common primary glomerulonephritis worldwide. Immune complexes, composed of galactose-deficient IgA1 and Gd-IgA1 autoantibodies, are deposited in the mesangial area of the glomeruli where they induce complement-mediated inflammation. This may result in the reduced kidney function, which can progress to end-stage kidney disease. Treatment options are very limited. It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR\>50ml/min/1.73m2 in IgA nephropathy, the KDIGO guidelines suggest a 6-month course of glucocorticoids. Many studies further showed that 6-month course of glucocorticoids with higher side effects and leading to discontinue of glucocorticoids course before the beneficial effect of 6months course. Currently monoclonal antibodies, that may affect the main axis of pathogenesis of IgA nephropathy and biological therapy such as Telitacicept, provides a new treatment option and altering or depletion or modulation of Gd-IgA1 producing B cells and plasma cells. At present, Telitacicept are used for clinical treatment in IgA nephropathy patient inside China, but still clear data on safety and effect, and patient's complete remission, repeated relapse data are unclear. This study is a Single center, Randomized, Open Label, Comparative study. In the study, around 60-100 patients with IgA nephropathy will be enrolled, and they will be treated with Telitacicept for 6 months on the basis of conventional treatment.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
Currently monoclonal antibodies, that may affect the main axis of pathogenesis of IgA nephropathy and biological therapy such as Telitacicept, provides a new treatment option and altering or depletion or modulation of Gd-IgA1 producing B cells and plasma cells. At present, Telitacicept are used for clinical treatment in IgA nephropathy patient inside China, but still clear data on safety and effect, and patient's complete remission, repeated relapse data are unclear.
Standard Supportive Care plus Corticosteroid(≤1mg/kg/d) without immunosuppressants
Drug: ACE Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization Drug: ARB Inhibitor (Treatment for proteinuria suppression and blood pressure regulation) - 2-3months before randomization
The First Affiliated hospital of Xuzhou Medical University
Xuzhou, Jiangsu, China
Complete remission of proteinuria
Proteinuria\<0.3g/24h
Time frame: Baseline/3months/6months
Partial remission of proteinuria
Proteinuria decline\>50%
Time frame: Baseline/3months/6months
Change from baseline to 6months in 24 Hours Urine Protein in g/24hrs
Compare the Baseline 24 Hours Urine Protein to 6month
Time frame: Baseline/3months/6months
Change from baseline to 6months in eGFR
Compare the baseline eGFR to 6months
Time frame: Baseline/3months/6months
Deterioration of renal function
The longitudinal decline of eGFR, serum creatinine arises\>50%, or eGFR decline\>25%, or onset of end-stage renal disease or dialysis treatment.
Time frame: Baseline/3months/6months
Change From Baseline Levels in Serum Immunoglobulin A (IgA) Levels in Serum Immunoglobulin G (IgG) Levels in Serum Immunoglobulin M (IgM)
The change in serum levels of IgA/IgG/IgM from baseline was reported.
Time frame: Baseline/ 3months/6months
Change From Baseline in Serum Complement C3 and C4 Levels
The change in serum component C3 and C4 from baseline were reported.
Time frame: Baseline/3months/6months
Percentage of Participants With Clinical Significant Abnormalities in Laboratory Assessments, including Blood Pressure
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
150
Laboratory investigation included haematology, biochemistry, urinalysis and Urine sediment analysis. Clinical significance was to be decided by the investigator. The systolic and diastolic blood pressure was measured after the participants have in a rested at least 3 minutes in seated position. Clinical significance was to be decided by the investigator.
Time frame: Baseline/3months/6months
Number of Participants With a Treatment-emergent Adverse Event (TEAE)
An Adverse event (AE) was any untoward medical occurrence in a clinical study participant. TEAEs were defined, within a dosing group, as AEs that started on or after the first dose of study treatment through 30 days after the last dose of study drug.
Time frame: Baseline/3months/6months
Number of Participants Who Experienced a Serious Adverse Event (SAE)
A serious adverse event (SAE) was an adverse event/reaction that results in any of the following outcomes: * Death * Is life-threatening (participant was at immediate risk of death at the time of the event; it does not refer to an event that hypothetically might have caused death if it were more severe) * Requires participant hospitalization (formal admission to a hospital for medical reasons) or prolongation of existing hospitalization * Results in persistent or significant disability/incapacity (ie, there was a substantial disruption of a person's ability to carry out normal life functions) * Is a congenital anomaly/birth defect
Time frame: Baseline/3months/6months