Rituximab and RASi in Patients With IgAN

• Status: Recruiting
• Trial end date: 2023-12-31
• 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: CHENNAN
• 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. 18 to 75 of age, male or female;

• 2. primary IgA nephropathy confirmed by renal biopsy

• 3. eGFR>30ml/min/1.73m2(calculated according to the CKD-EPI formula);

• 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<130/80 mmHg；

• 5. Serum albumin > 25g/L;

• 6. 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. Evidence of the use of glucocorticoids for immunosuppressive therapy, 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. Clinical confirmation of cirrhosis, chronic active liver disease, or hepatitis B, C, or HIV which 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.

• 9. Laboratory tests meeting the following criteria should be excluded:

(1) Hemoglobin <80g/L; (2) Platelet <80×10^9/L; (3) Neutrophils < 1.0×10^9/L; (4) Aspartic acid aminotransferase (AST) or alanine aminotransferase (ALT) >2.5× normal upper limit, except for the correlation with the primary disease;

• 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. Weight less than 50kg should be excluded;

• 17. Other researchers judge the patients unsuitable for inclusion in the study