Phase
Condition
Nephropathy
Kidney Disease
Nephritis
Treatment
RAS 2410
Rituximab
Clinical Study ID
Ages 18-75 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
- 18 to 75 of age, male or female;
- primary IgA nephropathy confirmed by renal biopsy
- eGFR>30ml/min/1.73m2(calculated according to the CKD-EPI formula);
After using maximum tolerated doses of ACEI and/or ARB for 3 months, thefollowing two points should be met:
24h proteinuria ≥1g;
Bp<130/80 mmHg;
- Serum albumin > 25g/L;
- 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 proportionof sclerosis was low ( spherical or segmental sclerosis ball < 50 % ), andinterstitial fibrosis was low ( below T2 ).
Exclusion
Exclusion Criteria:
- Evidence of the use of glucocorticoids for immunosuppressive therapy, such as:nephrotic syndrome, pathology for small lesions with IgA nephropathy. or theproportion of crescents confirmed by renal biopsy within 12 months was morethan 50 %.
- Clinical confirmation of cirrhosis, chronic active liver disease, or hepatitisB, C, or HIV which can detect viral replication;
- Clinically confirmed IgA nephropathy secondary to systemic diseases such assystemic lupus erythematosus, allergic purpura.
- Patients with non-simple IgA nephropathy, such as diabetic nephropathy orobesity-related nephropathy.
- A history of active systemic infection or severe infection occurred one monthbefore enrollment.
- Those who are pregnant or lactating or unwilling to take contraceptivemeasures.
- Current or recent ( within 30 days ) exposure to any research drug.
- Patients with allergic reactions to rituximab and / or known allergicreactions.
- 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× normalupper limit, except for the correlation with the primary disease;
- Continuous use of hormones or other immunosuppressive therapy in the past 6months;
- Accompanying or past malignant tumors, except for fully treated skin basal orsquamous cell carcinoma or cervical carcinoma in situ;
- History of psychosis may interfere with normal participation in this study;
- Patients with major heart or lung diseases (including obstructive pulmonarydisease);
- In acute and chronic tuberculosis infection period (tuberculin test positive,chest X-ray suspected tuberculosis patients);
- Patients with history of immunodeficiency, including other acquired orcongenital immunodeficiency diseases, or a history of organ transplantation;
- Weight less than 50kg should be excluded;
- Other researchers judge the patients unsuitable for inclusion in the study
Study Design
Study Description
Connect with a study center
Ruijin Hospital, Shanghai JiaoTong University School of Medicine
Shanghai, Shanghai
ChinaSite Not Available

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