UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000014 |
|---|---|
| Receipt number | R000000024 |
| Scientific Title | A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood |
| Date of disclosure of the study information | 2005/08/01 |
| Last modified on | 2008/08/01 13:30:30 |
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Basic information
Public title
A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Acronym
A randomized controlled trial of cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Scientific Title
A multicenter randomized controlled trial cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
Scientific Title:Acronym
A randomized controlled trial of cyclosporine treatment for frequently relapsing nephrotic syndrome in childhood
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 administration methods, 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 survival
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Cyclosporine C0 monitoring with 80-100ng/mL for first 6 months and with 60-80ng/mL for the following 18 months.
Interventions/Control_2
Cyclosporine C0 monitoring with 80-100ng/mL for first 6 months and Cyclosporine administration of 2.5mg/kg per day for the following 18 months.
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
| Not applicable |
Age-upper limit
| 18 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1.Primary nephrotic syndrome.
2.Frequently relapsing, based on the International study of kidney disease in children.
3.Biopsy diagnoses of MCNS, where a renal biopsy has been performed before eligibility.
4.Aged under 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-Schönlein nephritis, systemic lupus erythematosus).
2.History of cyclosporine administration.
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masahiro Ikeda |
Organization
Tokyo Metropolitan Children's Hospital
Division name
Department of Nephrology
Zip code
Address
1-3-1Umezono Kiyose City,Tokyo
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Japanese Study Group of Renal Disease in Children
Division name
Department of Nephrology,Tokyo Metropolitan Children's Hospital
Zip code
Address
1-3-1Umezono Kiyose City,Tokyo
TEL
Homepage URL
Sponsor or person
Institute
Japanese Study Group of Renal Disease in Children
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation,Japan
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
| 1995 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 1996 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2002 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
| 2007 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2007 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2007 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2005 | Year | 06 | Month | 20 | Day |
Last modified on
| 2008 | Year | 08 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000024
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
