IgAN
Conditions
Interventions
Rituximab group:Rituximab+RASi
control group:RASi
Sponsors
Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 75 years male or female; 2. primary IgA nephropathy confirmed by renal biopsy in 2 years 3. eGFR>30ml/min/1.73m2 4. After using maximum tolerated doses of ACEI and/or ARB for 3 months, the following two points should be met: (1) 24h proteinuria >= 1g; (2) Bp 25g/L; 6. Sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Evidence of the use of glucocorticoids for immunosuppressive therapy, such as: Nephrotic syndrome, pathogenic manifestations: MCGN combined with IgA nephropathy;Or crescent > 30% confirmed by kidney biopsy within 12 months; Or the presence of large crescent (the crescent occupies more than 50% of the renal capsule);Or annular crescent; 2. Clinical confirmation of cirrhosis, chronic active liver disease, or hepatitis B, C, or HIV which can detect viral replication; 3. IgA nephropathy secondary to systemic lupus erythematosus, purpura and other systemic diseases; 4. A history of active systemic infection or severe infection occurred within one month before enrollment; 5. Pregnancy, lactation or reluctance to use contraception; 6. Present or recent (within 30 days) exposure to any research drugs; 7. Patients with anaphylaxis and/or known anaphylaxis to rituximab; 8. Laboratory tests meeting the following criteria should be excluded: (1) Hemoglobin 2.5* normal upper limit, except for the correlation with the primary disease; 9. Continued hormonal or other immunosuppressive therapy for the past 6 months; 10. Accompanied or prior malignancy, except for adequately treated basal or squamous cell carcinomas or carcinoma in situ of the cervix; 11. A history of mental illness may interfere with normal participation in the study; 12. Major heart or lung disease (including obstructive pulmonary disease); 13. In acute and chronic tuberculosis infection period (positive tuberculin test, patients with suspicious tuberculous foci on chest radiograph); 14. A history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 15. Weight less than 50kg should be excluded; 16. Other researchers judge the patients unsuitable for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in proteinuria levels over 1 year compared with baseline;Changes in Gd-IgA1 levels;Incidence of adverse events;Incidence of ESRD;The proportion of 50% reduction in eGFR levels or doubling serum creatinine compared with baseline;Incidence of infection; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of 50% reduction in mean urinary protein compared with baseline over 1 year;The proportion of 50% reduction in mean urinary protein compared with baseline over 6 months;Changes in proteinuria levels over 6 months compared with baseline;Changes in eGFR levels over 1 year compared with baseline; | — |
Countries
China
Contacts
Public ContactNan Chen
Department of Nephrology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine
Outcome results
None listed