UMIN ID: C000000363
Registered date:14/05/2007
A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with diffuse mesangial prolideration in children:A randomized controlled trial of efficacy and safety
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | IgA nephropathy in children |
| Date of first enrollment | 2001/08/01 |
| Target sample size | 80 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | prednisolone+mizoribine for 2 years prednisolone+mizoribine+warfarin+dipyridamole for 2 years |
Outcome(s)
| Primary Outcome | Disappearance rate of proteinuria |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 2years-old |
|---|---|
| Age maximum | 18years-old |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | 1.Systemic diseases defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus, etc) 2.Medical history of allergy or hypersensitivity reactions to prednisolone, mizoribine, warfarin or dipyridamole 3.Chronic renal dysfunction 4.Active infectious disease 5.Severe liver disfunction 6.History of corticosteroid and immunosupressive drug use 7.Pregnancy 8.Judged inappropriate for this study by the physicians |
Related Information
| Primary Sponsor | The Japanese Pediatric IgA Nephropathy of Treatment Study Group |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | The Kidney Foundation, Japan |
| Secondary ID(s) |
Contact
| public contact | |
| Name | |
| Address | Japan |
| Telephone | 073-441-633 |
| Affiliation | The Japanese Pediatric IgA Nephropathy of Department of Pediatrics, Wakayama Medical University |
| scientific contact | |
| Name | Norishige Yoshikawa |
| Address | 811-1 Kimiidera Wakayama City Wakayama Japan |
| Telephone | |
| Affiliation | Wakayama Medical University Department of Pediatrics |