A Study of RC18 Administered Subcutaneously to Subjects With IgA(Immunoglobulin A) Nephropathy

This is an interventional treatment trial for IgA Nephropathy Read More

Inclusion Criteria:

1. Signing the informed consent;
2. Biopsy confirmed diagnosis of IgA nephropathy;
3. Male or female, between 18 and 70 years age;
4. Before randomization, 24-hour urine protein excretion of ≥1g/24h in every screening visit;
5. Estimated glomerular filtration rate (eGFR) (CKD-EPI formula) of >45 ml/min per 1.73m2;
6. Have received the ACEI(Angiotension converting enzyme inhibitors)/ARB(Angiotensin receptor blocker) standard treatment for 24 weeks prior to randomization, and have stabled the dosage (within the maximum tolerated dosage) for 4 weeks prior to randomization.

Exclusion Criteria:

1. Significant abnormalities in clinical laboratory values (including, but not limited to, the following indicators)：

   Items Abnormal value WBC(white blood cell count) <3*10^9/L PMN(Neutrophil count) <1.5*10^9/L HGB(hemoglobin) <85g/L PLT(blood platelet count) <80*10^9/L TBil(total bilirubin) >1.5*ULN ALT(Alanine aminotransferase) >3*ULN AST( Aspartate transaminase) >3*ULN ALP(alkaline phosphatase) >2*ULN CK(creatine kinase) >5*ULN

2. Any secondary IgA nephropathy caused by Henoch-Schönlein purpura, ankylosing spondylitis, systemic lupus erythematosus, sjogren syndrome, viral hepatitis, liver cirrhosis, rheumatoid arthritis, mixed connective tissue disease, polyarteritis nodosa, erythema nodosum, psoriasis, ulcerative colitis, crohn's disease, tumor, AIDS ,etc.;
3. Any nephropathy with special pathologic or clinical types, such as nephrotic syndrome, crescentic glomerulonephritis(with >50% of biopsied glomeruli), IgA nephropathy with minimal change disease (MCD-IgAN); and IgA nephropathy requiring corticosteroids treatment.
4. Suffering from cardiovascular and cerebrovascular events (myocardial infarction, unstable angina, ventricular arrhythmia, New York heart association grade III-IV heart failure, stroke, etc.) within the last 12 weeks;
5. Treating with systemic corticosteroids drug(excluding topical or nasal steroids) within 6 months prior to randomizing;
6. Treating with systemic immunosuppressor within 6 months prior to randomizing: cyclophosphamide, azathioprine, mycophenolate mofetil, leflunomide, tacrolimus, cyclosporine, rituximab, tripterygium wilfordii, etc.;
7. Requiring hospitalization or intravenous antibiotics treatment due to active infection within 6 months prior to randomizing;
8. Active tuberculosis or latent carrier;
9. Positive in herpes zoster, HIV antibody or HCV antibody;
10. Active hepatitis or severe liver disease, and HBV infection (According to the HBV screening test, ①excluded the HBsAg-positive; ②HBsAg-negative and HBcAb-positive, the HBV-DNA should be tested to determine the situation: the HBV-DNA positive subjects should be excluded, while the HBV-DNA negative subjects can participated in.)
11. With malignant tumors;
12. Pregnancy or lactation, or patients with family planning during the experiment;
13. Inevitably administrate nephrotoxic drugs during the study period;
14. Allergy to human biological products;
15. Receiving any other experimental drug 4 weeks or 5 times half-life of the experimental drug (up to the longer time) prior to randomizing;
16. Not suitable for the study judged by investigator.