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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: JPRN
Last refreshed on: 2 April 2019
Main ID:  JPRN-C000000375
Date of registration: 01/04/2006
Prospective Registration: No
Primary sponsor: The Japanese Pediatric IgA Nephropathy of Treatment Study Group
Public title: A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children.
Scientific title:
Date of first enrolment: 1998/08/01
Target sample size: 20
Recruitment status: Complete: follow-up complete
Study type:  Interventional
Study design:  Single arm Non-randomized  
Phase:  Not selected
Countries of recruitment
Name: Koichi Nakanishi   
Address:  811-1 Kimiidera Wakayama City Wakayama Japan
Affiliation:  The Japanese Pediatric IgA Nephropathy of Treatment Study Group Department of Pediatrics, Wakayama Medical University
Name: Norishige Yoshikawa   
Address:  811-1 Kimiidera Wakayama City Wakayama Japan
Affiliation:  Wakayama Medical University Department of Pediatrics
Key inclusion & exclusion criteria
Inclusion criteria: 1.Newly biopsy proven IgA nephropathy with diffuse mesangial proliferation
2.Nephrotic syndrome (proteinuria with an early morning urinary protein>300 mg/dL and hypoproteinemia with serum total. protein level <6.0 g/dL).
3.Aged 2 to 18 years
4.Written informed consent from the patients' parents or legal guardians

Exclusion 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 prednisolone, mizorobine, warfarin or dipyridamole
3.Chronic renal dysfunction
4.Active infectious disease
5.Severe liver disfunction
6.History of corticosteroid and immunosupression administration
8.Judged inappropriate for this study by the physicians

Age minimum: 2years-old
Age maximum: 18years-old
Gender: Male and Female
Health Condition(s) or Problem(s) studied
IgA nephropathy in children
prednisolone+mizoribine+warfarin+dipyridamole for 2 years
Primary Outcome(s)
Disappearance rate of proteinuria
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
The Kidney Foundation, Japan
Secondary Sponsor(s)
Ethics review
Approval date:
Results available:
Date Posted:
Date Completed:
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