A study to evaluate safety and activity in treatment of IgAN patients using Rituximab in combination with RASi(ACEI and/or ARB) compared with RASi.
IgA nephropathy (IgAN, IgA nephropathy), is currently the most common glomerular disease worldwide, which is characterized by High population quantity, wide distribution, strong heterogeneity. Diagnosis of Urinary protein control level within 1 year is one of the important predictors of renal failure in IgAN patients.Previous studies have shown that patients with renal insufficiency, hypertension, or urinary protein \> 1g at 24h during renal biopsy, and those with poor urinary protein control within 1 year of follow-up, have a higher risk of disease progression, and more than 30-50% of patients will develop into end-stage renal disease (ESRD) within 10 years. The recommended treatments for IgAN in the KDIGO guidelines include: RASi, glucocorticoid, immunosuppressor, antiplatelet drugs, lipid-lowering drugs, etc. Several trials have demonstrated the benefit of RASi in retarding disease progression in IgAN patients with proteinuria, but there is currently no specific treatment for IgAN. In recent years, it has been found that excessive production of Galactos-deficient IgA1 is one of the initiating factors of the pathogenesis of IgAN. Infection by pathogenic microorganisms induces lymphocytes in IgAN patients to produce anti-GD-IgA1 autoantibodies (second strike), which forms circulating immune complexes to deposit in the kidney and activates complement, which is an important pathogenesis of IgAN.However, recent studies have suggested that B-cell depletion therapy is effective for many aabs mediated renal diseases (e.g., membranous nephropathy, lupus nephritis, etc.). Rituximab, which combined with CD20 antigen on the B cell surface, can deplete B cells and play a therapeutic role by reducing antibody production. Therefore, the treatment of rituximab has potential therapeutic value for IgAN patients as well. However, there were very few studies which have shown the efficacy and safety of rituximab in the treatment of IgA nephropathy, only groups reported abroad, and the results were inconsistent. At present, there have been no randomized controlled studies to verify the safety and efficacy of rituximab in the treatment of IgA nephropathy, especially in Chinese with high incidence of IgAN. In this study, treatment of rituximab combining with RASi will be compared with RASi for IgAN patients, to explore an effective and safer regimen for IgAN, so as to bring more hope to patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
116
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China
Changes in proteinuria levels over 1 year compared with baseline
Primary outcome included changes in proteinuria levels over 1 year compared with baseline
Time frame: 1 year
The proportion of 50% reduction in mean urinary protein compared with baseline over 1 year
Statistical data of proportion of 50% reduction in mean urinary protein compared with baseline over 1 year
Time frame: 1 year
The proportion of 50% reduction in mean urinary protein compared with baseline over 6 months
Statistical data of proportion of 50% reduction in mean urinary protein compared with baseline over 6 months
Time frame: 6 months
Changes in proteinuria levels over 6 months compared with baseline
Secondary Outcome included changes in proteinuria levels over 6 months compared with baseline
Time frame: 6 months
Changes in eGFR levels over 1 year compared with baseline
To evaluate the efficacy of treatment in renal function
Time frame: 1 year
Changes in Gd-IgA1 levels
To observe the changes in GD-IGA1 level
Time frame: 1 year
Incidence of adverse events
Record the safety of Interventional drugs
Time frame: 1 year
Incidence of ESRD
Evaluate the efficacy of treatment
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Time frame: 1 year
The proportion of 50% reduction in eGFR levels or doubling serum creatinine compared with baseline
To evaluate the renal function
Time frame: 1 year
Incidence of infection
To evaluate the safety of Rituximab
Time frame: 1 year