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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000363
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute The Japanese Pediatric IgA Nephropathy of
Treatment Study Group
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000435

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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