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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000004204
Receipt No. R000005052
Scientific Title A multi-center randomized controlled trial of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)
Date of disclosure of the study information 2010/10/01
Last modified on 2021/03/17

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Basic information
Public title A multi-center randomized controlled trial of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)
Acronym A RCT of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)
Scientific Title A multi-center randomized controlled trial of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)
Scientific Title:Acronym A RCT of tacrolimus versus cyclosporine for frequently relapsing nephrotic syndrome in children (JSKDC06)
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 To demonstrate the non-inferiority of relapse-free time of taclorimus compared with cyclosporine for children with frequently relapsing nephrotic syndrome
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relapse-free time
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 NO
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Cyclosporine for 2 years
Interventions/Control_2 Tacrolimus 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)The initial episode of idiopathic nephrotic syndrome
(2)Treated with predonisolone therapy based on the International study of kidney disease
(3)Aged two years under 18 years
(4)Diagnosis of FRNS has been performed within 3 months before eligibility
(5)Diagnosis of steroid sensitive NS has been performed within the third week after the onset of PSL treatment
(6)Patient will be able to go to hospital during therapy
(7)Written informed consent from the patients' parents or legal guardians
Key exclusion criteria (1)Other renal nephrotic syndrome (IgA nephropathy)
(2)History of Henoch-Schounlein nephritis, systemic lupus erythematosus or secondary nephrotic syndrome
(3)History of steroid resistant NS
(4)Prior treatment of cyclosporine or tacrolimus
(5)History of immunosuppressants administration against nephrotic syndrome within one month before eligibility
(6)History of allergy or hypersensitivity reactions to cyclosporine or tacrolimus
(7)Either father or mother has diagnosed with diabetes mellitus
(8)Fasting blood glucose level more than 110 mg/dL/casual blood glucose level more than 200 mg/dL or HbA1c(NSGP) more than 6.4%, History of diabetes mellitus that needs medical attention administration
(9)Body Mass Index more than 30
(10)Uncontrollable hypertension
(11)Renal dysfunction (creatinine clearance < 60 mL/min)
(12)Severe liver dysfunction
(13)Active infectious disease
(14)Women during pregnancy or who wish pregnancy during therapy
(15)Patients enrolling another clinical trials
(16)Judged inappropriate for this study by the physicians
Target sample size 120

Research contact person
Name of lead principal investigator
1st name Kenji
Middle name
Last name Ishikura
Organization University School of Medicine
Division name Department of Pediatrics
Zip code 252-0373
Address 1-15-1 Kitazato, Minami-ku, Sagamihara City, Kanagawa
TEL 042-778-8111
Email lxkenzo@gmail.com

Public contact
Name of contact person
1st name Yuko
Middle name
Last name Shima
Organization Japanese Study Group of Kidney Disease in Children
Division name Department of Pediatrics, Wakayama Medical University
Zip code 641-8510
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 Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Review Board of NCCHD
Address 2-10-1 Ookura, Setagaya-ku, TOKYO
Tel 03-3416-0181
Email rinken@ncchd.go.jp

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
2010 Year 10 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 No longer recruiting
Date of protocol fixation
2010 Year 08 Month 15 Day
Date of IRB
Anticipated trial start date
2010 Year 10 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2010 Year 09 Month 14 Day
Last modified on
2021 Year 03 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005052

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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