UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000363 |
|---|---|
| Receipt number | R000000435 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2007/05/14 |
| Last modified on | 2013/12/25 10:03:22 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
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
Acronym
A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole: A randomized controlled trial(JPIGANTS01)
Scientific Title
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
Scientific Title:Acronym
A combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole: A randomized controlled trial(JPIGANTS01)
Region
| Japan |
Condition
Condition
IgA nephropathy in children
Classification by specialty
| Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
By comparing a combination of prednisolone and mizoribine and a combination of prednisolone, mizoribine, warfarin and dipyridamole, the better is selected as a standard treatment for IgA nephropathy in children in our group.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Disappearance rate of proteinuria
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
prednisolone+mizoribine for 2 years
Interventions/Control_2
prednisolone+mizoribine+warfarin+dipyridamole for 2 years
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 2 | years-old | <= |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Newly biopsy proven IgA nephropathy with diffuse mesangial proliferation
2.Aged 2 to 18 years
3.Written informed consent from the patients' parents or legal guardians
Key exclusion 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
Target sample size
80
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Norishige Yoshikawa |
Organization
Wakayama Medical University
Division name
Department of Pediatrics
Zip code
Address
811-1 Kimiidera Wakayama City Wakayama
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
The Japanese Pediatric IgA Nephropathy of
Division name
Department of Pediatrics, Wakayama Medical University
Zip code
Address
TEL
073-441-633
Homepage URL
Sponsor or person
Institute
The Japanese Pediatric IgA Nephropathy of
Treatment Study Group
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 05 | Month | 14 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Completed
Date of protocol fixation
| 2001 | Year | 06 | Month | 15 | Day |
Date of IRB
Anticipated trial start date
| 2001 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2006 | Year | 03 | Month | 23 | Day |
Last modified on
| 2013 | Year | 12 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000435
