UMIN ID: C000000014
Registered date:01/08/2005
A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Frequently relapsing nephrotic syndrome in children |
| Date of first enrollment | 1996/01/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Cyclosporine C0 monitoring with 80-100ng/mL for first 6 months and with 60-80ng/mL for the following 18 months. Cyclosporine C0 monitoring with 80-100ng/mL for first 6 months and Cyclosporine administration of 2.5mg/kg per day for the following 18 months. |
Outcome(s)
| Primary Outcome | relapse-free survival |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | Not applicable |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.History of cyclosporine administration. |
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 | 1-3-1Umezono Kiyose City,Tokyo Japan |
| Telephone | |
| Affiliation | Japanese Study Group of Renal Disease in Children Department of Nephrology,Tokyo Metropolitan Children's Hospital |
| scientific contact | |
| Name | Masahiro Ikeda |
| Address | 1-3-1Umezono Kiyose City,Tokyo Japan |
| Telephone | |
| Affiliation | Tokyo Metropolitan Children's Hospital Department of Nephrology |