UMIN ID: C000000006
Registered date:01/08/2005
Lisinopril only and a combination of lisinopril and losartan for IgA nephropathy with focal mesangial proliferation 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 | 2005/01/01 |
| Target sample size | 110 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Lisinopril for 2 years Lisinopril+losartan 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.Other renal or systemic forms of nephrotic syndrome defined on renal biopsy, clinical features or serology (Henoch-Schönlein nephritis, systemic lupus erythematosus). 2.Medical history of allergy or hypersensitivity reactions to lisinopuril and losartan. 3.Chronic renal dysfunction. 4.Active infectious disease. 5.Severe liver disfunction. 6.History of steroid, immunosupression, ACEI and ARB administration. 7.History of Saireito or dipilidamol administration. 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 | The Ministry of Health,Labour and Welfare |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Nakanishi |
| Address | 811-1 KImiidera Wakayama City 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 |