A Phase III, Double-Blind, Randomized Study of IDEC-C2B8 in Patients with Childhood-onset Refractory Nephrotic Syndrome
- Conditions
- Childhood-onset Refractory Nephrotic Syndrome
- Registration Number
- JPRN-UMIN000001405
- Lead Sponsor
- Research group of Childhood-onset Refractory Nephrotic Syndrome
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 60
Not provided
1. History of inflammatory nephritis such as IgA nephritis. 2. History of immunosuppressive treatment for INS other than cyclosporine A, tacrolimus, cyclophosphamide, mizoribine, azathioprine, mycophenolate mofetil and chlorambucil 3. History of serious infectious diseases such as pulmonary tuberculosis and deep-seated fungal diseases 4. Positive for HCV antibody, HBs antigen, HBc antibody and HIV antibody 5. Having received a live vaccine within 4 weeks prior to screening 6.Known hypertension which is uncontrollable with conventional anti-hypertensive 7. Deteriorated kidney function, e.g. estimated GFR<60mL/min./1.73m2 8. Deteriorated liver function, e.g., AST or ALT > 2.5 x upper limit of normal value 9. Presence or history of angina pectoris, cardiac failure, myocardial infarction and/or serious arrhythmia grade 4 in "Common Terminology Criteria for Adverse Events (ver. 3.0)" 10. Presence or history of auto-immune diseases such as Hashimoto disease (struma lymphomatosa), Crohn's disease, ulcerative colitis, rheumatoid arthritis, idiopathic thrombocytopenic purpura, systemic lupus erythematosus, autoimmune hemolytic anemia, scleroderma or vascular purpura 11. Presence or history of cancer 12. History of organ transplantation 13. History of allergic reaction to methylprednisolone, acetaminophen and/or d-chlorpheniramine maleate 14. Presence of hematological disorder, e.g., WBC < 2,000/mcL, neutrophil < 1,500/mcL, PLT < 50,000/mcL 15. History of receiving any kinds of monoclonal antibody therapy 16. Having received any investigational agent within 6 months prior to enrollment, or participating other clinical studies 17. Pregnant subjects or subjects who do not agree with contraception during the study period (Negative HCG result is required at screening for female subjects after the first menstruation.) 18.Judged inappropriate for this study by the physicians
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method relapse-free duration
- Secondary Outcome Measures
Name Time Method