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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000005103
Receipt No. R000006067
Scientific Title A multi-center randomized controlled trial Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing steroid sensitive nephrotic syndrome in children (JSKDC05)
Date of disclosure of the study information 2011/03/01
Last modified on 2017/08/07

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Basic information
Public title A multi-center randomized controlled trial Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing steroid sensitive nephrotic syndrome in children (JSKDC05)
Acronym A RCT Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing SSNS in children (JSKDC05)
Scientific Title A multi-center randomized controlled trial Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing steroid sensitive nephrotic syndrome in children (JSKDC05)
Scientific Title:Acronym A RCT Comparing Standard Prednisolone therapy with Standard Prednisolone therapy + High-dose Mizoribine for the Treatment of early-relapsing SSNS in children (JSKDC05)
Region
Japan

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

Objectives
Narrative objectives1 To demonstrate the superiority of Standard Prednisolone therapy + High-dose Mizoribine over Standard Prednisolone therapy for time to frequent relapse in early-relapsing steroid sensitive nephrotic syndrome in children
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Time to frequent relapse
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

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 A: Standard Prednisolone therapy
Interventions/Control_2 B: Standard Prednisolone therapy + High-dose Mizoribine
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
11 years-old >
Gender Male and Female
Key inclusion criteria (1)The initial episode of idiopathic nephrotic syndrome
(2)Treated with PSL therapy based on the International study of kidney disease and Diagnosed first relapse within 6 months when remission at first episode was confirmed
(3)Aged two years under 11 years
(4)Diagnosis of steroid sensitive has been performed within the third week
after the onset of PSL therapy against first relapse
(5)Patient will be able to go to hospital during therapy
(6)Written informed consent from the patients' parents or legal guardians
Key exclusion criteria (1)Other renal nephrotic syndrome(persistent hematuria)
(2)History of Henoch-Sch&ouml;nlein nephritis, systemic lupus erythematosus or secondary nephrotic syndrome
(3)History of steroid resistant
(4)History of immunosuppressants administration against nephrotic syndrome
(5)Uncontrollable hypertension
(6)Renal dysfunction(creatinine clearance < 90 mL/min)
(7)Severe liver dysfunction
(8)Patients enrolling another clinical trials at the first relapse
(9)Judged inappropriate for this study by the physicians
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Koichi Nakanishi
Organization Wakayama Medical University
Division name Department of Pediatrics
Zip code
Address 811-1 Kimiidera Wakayama City Wakayama
TEL 073-441-0633
Email knakanis@wakayama-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Japanese Study Group of Kidney Disease in Children
Organization Wakayama Medical University
Division name Department of Pediatrics
Zip code
Address 811-1 Kimiidera Wakayama City Wakayama
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
2011 Year 03 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 Open public recruiting
Date of protocol fixation
2010 Year 12 Month 10 Day
Date of IRB
Anticipated trial start date
2011 Year 02 Month 01 Day
Last follow-up date
2021 Year 01 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2011 Year 02 Month 18 Day
Last modified on
2017 Year 08 Month 07 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006067

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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