UMIN ID: C000000379
Registered date:01/04/2006
Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Steroid-sensitive nephrotic syndrome |
| Date of first enrollment | 2001/04/01 |
| Target sample size | 50 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | prednisolone mizoribine+prednisolone |
Outcome(s)
| Primary Outcome | Relapse-free period |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 1years-old |
|---|---|
| Age maximum | 10years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.History of relapse. 2.Medical history of allergy or hypersensitivity reactions to mizoribine. 3.Poorly controlled hypertension. 4.Chronic renal dysfunction. 5.Active infectious disease. 6.Severe liver disfunction. 7.History of saireito and immunosupression administration. 8.Pregnancy. 9.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 | Japan |
| Telephone | |
| Affiliation | Japanese Study Group of Renal Disease in Children(JSRDC) Department of Nephrology,Tokyo Metropolitan Children's Hospital |
| scientific contact | |
| Name | Norishige Yosikawa |
| Address | 811-1 Kimiidera Wakayama City Wakayama Japan |
| Telephone | |
| Affiliation | Wakayama Medical University Department of Pediatrics |