UMIN ID: C000000378
Registered date:01/04/2006
A combination of methylprednisolone and prednisolone and a combination of Methylprednisolone, prednisolone and mizoribine for systemic lupus erythematosus in children: A randomized controlled trial of efficacy and safety izolibin for (JSRDC04)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | systematic lupus erythematosus |
| Date of first enrollment | 1995/03/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Methylprednisolone+prednisolone Methylprednisolone+prednisolone+mizoribine |
Outcome(s)
| Primary Outcome | Cumulative flare rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 2years-old |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Chronic rheumatoid arthritis, diffuse scleroderma or dermatomyositis. 2.History of immunosuppressive drugs administration. 3.Medical history of allergy or hypersensitivity reactions to mizoribine. 4.Poorly controlled hypertension. 5.Active infectious disease. 6.Severe liver disfunction. 7.Pregnancy. 8.Judged inappropriate for this study by the physicians. |
Related Information
| Primary Sponsor | Japanese Study Group of Renal Disease in Children(JSRDC) |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Kidney Foundation, Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | 1-3-1 Umezono Kiyose City, Tokyo Japan |
| Telephone | |
| Affiliation | Japanese Study Group of Renal Disease in Children(JSRDC) Department of Nephrology, Tokyo Metropolitan Children's Hospital |
| scientific contact | |
| Name | Masataka Honda |
| Address | 4-33-13 Daimachi Hachioji City,Tokyo Japan |
| Telephone | |
| Affiliation | Tokyo Metropolitan Children's Hospital Department of Pediatrics |