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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000014
Receipt No. R000000024
Scientific Title A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Date of disclosure of the study information 2005/08/01
Last modified on 2008/08/01

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Basic information
Public title A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Acronym A randomized controlled trial of cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Scientific Title A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Scientific Title:Acronym A randomized controlled trial of cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Region
Japan

Condition
Condition Frequently relapsing nephrotic syndrome in children
Classification by specialty
Nephrology Pediatrics
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 By comparing two administration methods, the better is selected as a standard treatment for frequently relapsing nephrotic syndrome 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 survival
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cyclosporine C0 monitoring with 80-100ng/mL for first 6 months and with 60-80ng/mL for the following 18 months.
Interventions/Control_2 Cyclosporine C0 monitoring with 80-100ng/mL for first 6 months and Cyclosporine administration of 2.5mg/kg per day for the following 18 months.
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

Not applicable
Age-upper limit
18 years-old >=
Gender Male and Female
Key inclusion criteria 1.Primary nephrotic syndrome.
2.Frequently relapsing, based on the International study of kidney disease in children.
3.Biopsy diagnoses of MCNS, where a renal biopsy has been performed before eligibility.
4.Aged under 18 years.
5.Written informed consent from the patients' parents or legal guardians.
Key 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.History of cyclosporine administration.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masahiro Ikeda
Organization Tokyo Metropolitan Children's Hospital
Division name Department of Nephrology
Zip code
Address 1-3-1Umezono Kiyose City,Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Japanese Study Group of Renal Disease in Children
Division name Department of Nephrology,Tokyo Metropolitan Children's Hospital
Zip code
Address 1-3-1Umezono Kiyose City,Tokyo
TEL
Homepage URL
Email

Sponsor
Institute Japanese Study Group of Renal Disease in Children
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
2005 Year 08 Month 01 Day

Related information
URL releasing protocol
Publication of results Published

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
1995 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
1996 Year 01 Month 01 Day
Last follow-up date
2002 Year 01 Month 01 Day
Date of closure to data entry
2007 Year 03 Month 01 Day
Date trial data considered complete
2007 Year 03 Month 01 Day
Date analysis concluded
2007 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2005 Year 06 Month 20 Day
Last modified on
2008 Year 08 Month 01 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000024

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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