UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005103 |
|---|---|
| Receipt number | 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 | 2021/03/01 15:43:12 |
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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-Schönlein 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 | Koichi |
| Middle name | |
| Last name | Nakanishi |
Organization
Graduate School of Medicine, University of Ryukyus
Division name
Department of Child Health and Welfare (Pediatrics)
Zip code
903-0125
Address
207, Uehara, Nishihara-cho,Nakagami-gun,Okinawa
TEL
098-895-1154
knakanis@wakayama-med.ac.jp
Public contact
Name of contact person
| 1st name | Yuko |
| Middle name | |
| Last name | Shima |
Organization
Wakayama Medical University
Division name
Department of Pediatrics
Zip code
641-8510
Address
811-1 Kimiidera Wakayama City Wakayama
TEL
073-441-0633
Homepage URL
jskdc@wakayama-med.ac.jp
Sponsor or person
Institute
Japanese Study Group of Kidney Disease in Children
Institute
Department
Personal name
Funding Source
Organization
None
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
Review Board of University of Ryukyus for Clinical Research
Address
207, Uehara, Nishihara-cho,Nakagami-gun,Okinawa
Tel
098-895-1154
krinken@acs.u-ryukyu.ac.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
| 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
No longer recruiting
Date of protocol fixation
| 2010 | Year | 12 | Month | 10 | Day |
Date of IRB
| 2019 | Year | 02 | Month | 26 | Day |
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
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006067
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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| Registered date | File name |
