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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000379
Receipt No. R000000469
Scientific Title Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)
Date of disclosure of the study information 2006/04/01
Last modified on 2008/10/30

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Basic information
Public title Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)
Acronym Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome in children: A randomized controlled trial (JSRDC06)
Scientific Title Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome relapsed within six mounths after first onset in children: A randomized controlled trial of efficacy and safety (JSRDC06)
Scientific Title:Acronym Prednisolone only and a combination of prednisolone and mizoribine for primary nephrotic syndrome in children: A randomized controlled trial (JSRDC06)
Region
Japan

Condition
Condition Steroid-sensitive nephrotic syndrome
Classification by specialty
Nephrology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By comparing prednisolone only and a combination of prednisolone and mizoribine, the better is selected as a standard treatment for for primary nephrotic syndrome relapsed within six mounths after first onset in children in our group.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse-free period
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
Interventions/Control_2 mizoribine+prednisolone
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
1 years-old <=
Age-upper limit
10 years-old >=
Gender Male and Female
Key inclusion criteria 1.Primary nephrotic syndrome (proteinuria with a urinary protein-creatinine ratio >1.8 and hypoalbuminemia with serum albumin level <2.5 g/dL).
2.Patients with treatment either based on the International study of kidney disease in children (ISKDC) or similar to ISKDC.
3.Steroid-sensitive nephrotic syndrome in first onset.
4.First replase happended within 6 mounths after first onset.
5.Aged twelve months to 18 years.
6.Written informed consent from the patients' parents or legal guardians.
Key exclusion criteria 1.History of relapse.
2.Medical history of allergy or hypersensitivity reactions to mizoribine.
3.Poorly controlled hypertension.
4.Chronic renal dysfunction.
5.Active infectious disease.
6.Severe liver disfunction.
7.History of saireito and immunosupression administration.
8.Pregnancy.
9.Judged inappropriate for this study by the physicians.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Norishige Yosikawa
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 Japanese Study Group of Renal Disease in Children(JSRDC)
Division name Department of Nephrology,Tokyo Metropolitan Children's Hospital
Zip code
Address
TEL
Homepage URL
Email

Sponsor
Institute Japanese Study Group of Renal Disease in Children(JSRDC)
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
2006 Year 04 Month 01 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 03 Month 10 Day
Date of IRB
Anticipated trial start date
2001 Year 04 Month 01 Day
Last follow-up date
2005 Year 03 Month 01 Day
Date of closure to data entry
2005 Year 06 Month 01 Day
Date trial data considered complete
2005 Year 06 Month 01 Day
Date analysis concluded
2005 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 29 Day
Last modified on
2008 Year 10 Month 30 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000469

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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