UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004204 |
|---|---|
| Receipt number | 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 19:23:25 |
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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
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
jskdc@wakayama-med.ac.jp
Sponsor or person
Institute
Japanese Study Group of Kidney Disease in Children
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005052
