UMIN ID: C000000007
Registered date:01/08/2005
A combination of cyclosporine and prednisolone and a combination of methylprednisolone, cyclosporine and prednisolone for steroid-resistant nephrotic syndrome in children: A randomized controlled study
Basic Information
| Recruitment status | |
|---|---|
| Health condition(s) or Problem(s) studied | Steroid-resistant nephrotic syndrome in children |
| Date of first enrollment | 2005/04/01 |
| Target sample size | 90 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cyclosporine+prednisolone treatment for 2 years Methylprednisolone+cyclosporine+prednisolone treatment for 2 years |
Outcome(s)
| Primary Outcome | Complete remission rate |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 1years-old |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Congenital nephrotic syndrome. 2.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 3.Medical history of allergy or hypersensitivity reactions to methylprednisolone and cyclosporine. 4.Poorly controlled hypertension. 5.Chronic renal dysfunction. 6.Active infectious disease. 7.Severe liver disfunction. 8.History of cyclosporine administration. 9.Pregnancy. 10.Judged inappropriate for this study by the physicians. |
Related Information
| Primary Sponsor | Japanese Study Group of Kidney Disease in Children |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | Ministry of Health, Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Kenji Ishikura |
| Address | 2-8-29 Musashidai Fuchu City, Tokyo Japan 183-8561 |
| Telephone | 042-300-5111 |
| info_jsrdc@jsrdc.org | |
| Affiliation | Japanese Study Group of Kidney Disease in Children Tokyo Metropolitan Children's Medical Center |
| scientific contact | |
| Name | Shuichi Ito |
| Address | 2-10-1 Okura Setagaya-ku, Tokyo Japan |
| Telephone | 03-3416-0181 |
| info_jsrdc@jsrdc.org | |
| Affiliation | National Center for Child Health and Development Department of Pediatric Nephrology and Rheumatology |