UMIN ID: C000000009
Registered date:01/08/2005
Treatment for steroid-resistant nephrotic syndrome in children: a combination of cyclosporine and prednisolone in minimal change and a combination of methylprednisolone, cyclosporine and prednisolone in FSGS
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Steroid-resistant nephrotic syndrome in children |
| Date of first enrollment | 2001/04/01 |
| Target sample size | 60 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cyclosporine+prednisolone Methylprednisolone+cyclosporine+prednisolone |
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 Renal Disease in Children |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Kidney Foundation,Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | |
| Affiliation | Japanese Study Group of Renal Disease in Children 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 |