UMIN ID: UMIN000001405
Registered date:02/10/2008
A Phase III, Double-Blind, Randomized Study of IDEC-C2B8 in Patients with Childhood-onset Refractory Nephrotic Syndrome
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Childhood-onset Refractory Nephrotic Syndrome |
| Date of first enrollment | 2008/10/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | IDEC-C2B8 placebo |
Outcome(s)
| Primary Outcome | relapse-free duration |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 2years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 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 |
Related Information
| Primary Sponsor | Research group of Childhood-onset Refractory Nephrotic Syndrome |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Center for Clinical Trials, Japan Medical Association |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| rcrns@med.kobe-u.ac.jp | |
| Affiliation | Kobe University Hospital Research group of Childhood-onset Refractory Nephrotic Syndrome |
| scientific contact | |
| Name | Kazumoto Iijima |
| Address | 5-1 Kusunoki-cho 7 chome Japan |
| Telephone | |
| Affiliation | Division of Child Health and Development Department of Pediatrics Kobe University Graduate School of medicine Department of Pediatrics |