Status:
COMPLETED
Rituximab and RASi in Patients with IgAN
Lead Sponsor:
Nan Chen,MD
Collaborating Sponsors:
Dongfang Hospital Affiliated to Tongji University
Shanghai Pudong New Area People's Hospital
Conditions:
IgA Nephropathy
Eligibility:
All Genders
18-75 years
Phase:
PHASE4
Brief 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.
Detailed Description
IgA nephropathy (IgAN, IgA nephropathy), is currently the most common glomerular disease worldwide, which is characterized by High population quantity, wide distribution, strong heterogeneity. Diagno...
Eligibility Criteria
Inclusion
- 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:
- 24h proteinuria ≥1g;
- 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 :
- ) 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
- 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
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 30 2024
Estimated Enrollment :
116 Patients enrolled
Trial Details
Trial ID
NCT04525729
Start Date
July 1 2020
End Date
March 30 2024
Last Update
March 14 2025
Active Locations (1)
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1
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai Municipality, China