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

• Status: Active, not recruiting
• Trial end date: 2023-10-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: XIEJINGYUAN
• Collaborators: Dongfang Hospital Affiliated to Tongji University; Ningbo Municipal Yinzhou District No.2 Hospital; Ruijin Hospital North Shanghai Jiao Tong University School of Medicine; Shanghai Pudong New Area People's Hospital; Sir Run Run Shaw Hospital; Third Affiliated Hospital, Sun Yat-Sen University; Xiamen Hongai Hospital
• Treatments: Rituximab

Criteria

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.