A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy
IgA Nephropathy
About this trial
This is an interventional treatment trial for IgA Nephropathy
Eligibility Criteria
Inclusion Criteria: Age 18-75 years old, no gender limit; Renal biopsy confirmed primary IgA nephropathy; Assess glomerular filtration rate ( eGFR )>30ml/min/1.73m2 (calculated according to the CKD-EPI formula); After 3 months of treatment with the maximum tolerated dose of ACEI and/or ARB, the following two points should be met: 1) 24hurinary protein ≥ 1g; 2) Blood pressure <130/80 mmHg; 5. Serum albumin> 25g/L; 6. Voluntarily sign the informed consent. Note : It is suggested that active IgAN patients should be selected. Active IgAN is specifically defined as conforming to any of the following : ) intradermal augmentation ( E1 ), ) crescentic body 0 - 50 % ( C1 / C2 ), ) fibrinoid necrosis, ) more interstitial inflammatory cell infiltration. At the same time, the proportion of sclerosis was low ( spherical or segmental sclerosis ball < 50 % ), and interstitial fibrosis was low ( below T2 ). Exclusion Criteria: Glucocorticoid used for immunosuppressive therapy indications, such as : nephrotic syndrome, pathology for small lesions with IgA nephropathy. or the proportion of crescents confirmed by renal biopsy within 12 months was more than 50 %. Clinically confirmed cirrhosis, chronic active liver disease or hepatitis B, hepatitis C or HIV can detect viral replication. Clinically confirmed IgA nephropathy secondary to systemic diseases such as systemic lupus erythematosus, allergic purpura. Patients with non-simple IgA nephropathy, such as diabetic nephropathy or obesity-related nephropathy. A history of active systemic infection or severe infection occurred one month before enrollment. Those who are pregnant or lactating or unwilling to take contraceptive measures. Current or recent ( within 30 days ) exposure to any research drug. 8. Patients with allergic reactions to rituximab and / or known allergic reactions. Patients with allergic reactions to rituximab and / or known allergic reactions. Laboratory tests should be excluded if they meet the following standards : (1) Hemoglobin <80g/L; (2) Platelets<80×109/L; (3) Neutrophils <1.0×109/L; (4) In addition to being related to the primary disease, aspartate aminotransferase (AST) or alanine aminotransferase (ALT)>2.5×upper limit of normal; 10. Continuous use of hormones or other immunosuppressive therapy in the past 6 months; 11. Accompanying or past malignant tumors, except for fully treated skin basal or squamous cell carcinoma or cervical carcinoma in situ; 12. History of psychosis may interfere with normal participation in this study; 13. Patients with major heart or lung diseases (including obstructive pulmonary disease); 14. In acute and chronic tuberculosis infection period (tuberculin test positive, chest X-ray suspected tuberculosis patients); 15. Patients with history of immunodeficiency, including other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 16. Low weight (weight < 50kg) should be excluded; 17. Other investigators judged patients unsuitable for the study.
Sites / Locations
- Ruijin Hospital, Shanghai Jiao Tong University School of Medicine
Arms of the Study
Arm 1
Arm 2
Experimental
No Intervention
Group A ( ACEi and / or ARB + rituximab group )
Group B ( ACEi and / or ARB )
Patients in the experimental group were treated with the maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and / or angiotensin II receptor blocker ( ARB ) combined with rituximab. The specific usage and dosage are as follows : On the basis of the use of ACEI and / or ARB, rituximab was used on D1 and D31 days, 1 g each time, intravenous drip, twice in total. Add 1 g rituximab at 6 months. All patients who received rituximab were given oral acetaminophen ( 1g ), diphenhydramine hydrochloride ( 50mg ) and intravenous methylprednisolone ( 40mg ) 30-60min before the beginning of infusion. ACEI and / or ARB were given daily maximum tolerable dose according to individual factors of subjects.
According to the individual factors of the subjects, the maximum tolerable dose of angiotensin converting enzyme inhibitor ( ACEI ) and / or angiotensin II receptor blocker ( ARB ) were used daily.