|
Main
|
|
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:
|
17 October 2023 |
|
Main ID: |
JPRN-C000000375 |
|
Date of registration:
|
01/04/2006 |
|
Prospective Registration:
|
No |
|
Primary sponsor: |
|
|
Public title:
|
A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children.
|
|
Scientific title:
|
A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children. - A combination of prednisolone, mizoribine, warfarin and dipyridamole for IgA nephropathy with nephrotic syndrome and diffuse mesangial proliferation in children. |
|
Date of first enrolment:
|
1998/08/01 |
|
Target sample size:
|
20 |
|
Recruitment status: |
Complete: follow-up complete |
|
URL:
|
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000470 |
|
Study type:
|
Interventional |
|
Study design:
|
Single arm Non-randomized
|
|
Phase:
|
Not selected
|
|
|
Countries of recruitment
|
|
Japan
| | | | | | | |
|
Contacts
|
|
Name:
|
Norishige Yoshikawa |
|
Address:
|
811-1 Kimiidera Wakayama City Wakayama
Japan |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
Wakayama Medical University Department of Pediatrics |
|
|
Name:
|
Koichi Nakanishi |
|
Address:
|
811-1 Kimiidera Wakayama City Wakayama
Japan |
|
Telephone:
|
|
|
Email:
|
|
|
Affiliation:
|
The Japanese Pediatric IgA Nephropathy of Treatment Study Group Department of Pediatrics, Wakayama Medical University |
| |
|
Key inclusion & exclusion criteria
|
Inclusion criteria:
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 7.Pregnancy 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
|
|
Intervention(s)
|
|
prednisolone+mizoribine+warfarin+dipyridamole for 2 years
|
|
Primary Outcome(s)
|
|
Disappearance rate of proteinuria
|
|
Source(s) of Monetary Support
|
|
The Kidney Foundation, Japan
|
|
Ethics review
|
Status: YES
Approval date:
Contact:
|
|
Results
|
|
Results available:
|
Yes |
|
Date Posted:
|
|
|
Date Completed:
|
01/07/2005 |
|
URL:
|
|
|
|