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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000008
Receipt No. R000000011
Scientific Title Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial
Date of disclosure of the study information 2005/08/01
Last modified on 2016/08/19

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Basic information
Public title Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial
Acronym Cyclosporine C2 monitaring: A randomized controlled trial(JSKDC03)
Scientific Title Cyclosporine C2 monitaring for frequently relapsing nephrotic syndrome in children: A randomized controlled trial
Scientific Title:Acronym Cyclosporine C2 monitaring: A randomized controlled trial(JSKDC03)
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 target cyclosporine C2 levels,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 rate
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -no one is 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 Cyclosporine C2 monitoring with higher target levels
Interventions/Control_2 Cyclosporine C2 monitoring by lower target levels
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
18 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.Frequently relapse or steroid independence, based on the International study of kidney disease in children.
3.Biopsy diagnoses of MCNS, MPGN or FSGS, where a renal biopsy has been performed within 12 months before eligibility.
4.Aged twelve months to 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-Sch&ouml;nlein nephritis, systemic lupus erythematosus).
2.History of steroid resistance.
3.Medical history of allergy or hypersensitivity reactions to cyclosporine.
4.Poorly controlled hypertension.
5.Chronic renal dysfunction.
6.Active infectious disease.
7.Severe liver disfunction.
8.History of cyclosporine administration.
9.Pregnancy.
10.Judged inappropriate for this study by the physicians.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazumoto Iijima
Organization Division of Child Health and Development
Kobe University Graduate School of medicine
Division name Department of Pediatrics
Zip code
Address 5-1 Kusunoki-cho 7 chome Kobe City
TEL 078-382-6093
Email iijima@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Nakanishi
Organization Japanese Study Group of Kidney Disease in Children
Division name Department of Pediatrics, Wakayama Medical University
Zip code
Address 811-1 KImiidera Wakayama City
TEL 073-441-0633
Homepage URL
Email jskdc@wakayama-med.ac.jp

Sponsor
Institute Japanese Study Group of Kidney Disease in Children
Institute
Department

Funding Source
Organization Ministry of Health, Labour and Welfare
Organization
Division
Category of Funding Organization Japanese Governmental office
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
2005 Year 04 Month 25 Day
Date of IRB
Anticipated trial start date
2005 Year 04 Month 01 Day
Last follow-up date
2012 Year 03 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
2005 Year 06 Month 14 Day
Last modified on
2016 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000011

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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