A Randomized, Controlled Clinical Study of Rituximab in Treatment of Primary IgA Nephropathy

RuijinHRIGA

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.

2020-06-20

2023-10-01

2023-10-01

Active (not recruiting)

Early phase I

116

Inclusion Criteria: 1. Age 18-75 years old, no gender limit; 2. Renal biopsy confirmed primary IgA nephropathy; 3. Assess glomerular filtration rate ( eGFR )\>30ml/min/1.73m2 (calculated according to the CKD-EPI formula); 4. 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 : 1. ) intradermal augmentation ( E1 ), 2. ) crescentic body 0 - 50 % ( C1 / C2 ), 3. ) fibrinoid necrosis, 4. ) 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: 1. 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 %. 2. Clinically confirmed cirrhosis, chronic active liver disease or hepatitis B, hepatitis C or HIV can detect viral replication. 3. Clinically confirmed IgA nephropathy secondary to systemic diseases such as systemic lupus erythematosus, allergic purpura. 4. Patients with non-simple IgA nephropathy, such as diabetic nephropathy or obesity-related nephropathy. 5. A history of active systemic infection or severe infection occurred one month before enrollment. 6. Those who are pregnant or lactating or unwilling to take contraceptive measures. 7. Current or recent ( within 30 days ) exposure to any research drug. 8. Patients with allergic reactions to rituximab and / or known allergic reactions. 8. Patients with allergic reactions to rituximab and / or known allergic reactions. 9. 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.

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2023-04-21