UMIN ID: UMIN000000747
Registered date:01/09/2007
Prednisolone therapy of the first episode of idopatic nephrotic syndrome in children: A Multi-center randomized controlled trial
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Idiopatic nephrotic syndrome in children |
| Date of first enrollment | 2007/09/01 |
| Target sample size | 250 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | PSL for 2 months PSL for 6 months |
Outcome(s)
| Primary Outcome | Time to frequent relapse |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 1years-old |
|---|---|
| Age maximum | 15years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1)Other renal nephrotic syndrome(IgA nephropathy) 2)Henoch-Sch&ouml;nlein nephritis, systemic lupus erythematosus 3)History of immunosuppressant administration. 4)Poorly controlled hypertension. 5)Renal dysfunction(creatinine clearance < 60 mL/min). 6)Active infectious disease. 7)Severe liver disfunction. 8)Pregnancy. 9)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 | Nakanishi |
| Address | Japan |
| Telephone | 073-441-0633 |
| jskdc@wakayama-med.ac.jp | |
| Affiliation | Japanese Study Group of Kidney Disease in Children Department of Pediatrics, Wakayama Medical University |
| scientific contact | |
| Name | Norishige Yoshikawa |
| Address | 811-1 Kimiidera Wakayama City Wakayama Japan |
| Telephone | 073-441-0633 |
| nori@wakayama-med.ac.jp | |
| Affiliation | Wakayama Medical University Department of Pediatrics |