UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004653 |
|---|---|
| Receipt number | R000003261 |
| Scientific Title | The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS |
| Date of disclosure of the study information | 2010/12/02 |
| Last modified on | 2010/12/02 13:40:03 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS
Acronym
The effects of cyclosporine in onset MCNS
Scientific Title
The clinical effects and safty of cyclosporine with rootine corticosteroid treatment in onset MCNS
Scientific Title:Acronym
The effects of cyclosporine in onset MCNS
Region
| Japan |
Condition
Condition
minimal change nephrotic syndrome
Classification by specialty
| Medicine in general | Nephrology | Clinical immunology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
From the viewpoint of medical administration, improvement in QOL and shortening of hospitalization are demanded in treatment of nephritic syndrome patients.
Therefore, we examined a trial in primary care of onset MCNS to evaluate the clinical effect, safety and hospitalization shortening of CsA combination therapy with MPT.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
shortening of hospitalization, reduction in adverse effects, prevention of relapse, reduction in dose of corticosteroid
Key secondary outcomes
reduction in days required for complete remission, blood and urine chemistry data of 6 and 12 months after discharge
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -but assessor(s) are blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
cyclosporine A 2-3mg/kg/day
Interventions/Control_2
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
| 16 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
minimal change nephrotic syndrome patients that do not have underlying disease
Key exclusion criteria
minimal change nephrotic syndrome patients that have underlying disease
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuhito hirawa |
Organization
Yokohama city university medical center
Division name
division of Nephrology and Hypertension
Zip code
Address
4-57 urafunecho minamiku yokohama-shi kanagawa-ken Japan
TEL
045-261-5656
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuhito hirawa |
Organization
Yokohama city university medical center
Division name
division of Nephrology and Hypertension
Zip code
Address
4-57 urafunecho minamiku yokohama-shi kanagawa-ken Japan
TEL
045-261-5656
Homepage URL
Sponsor or person
Institute
Yokohama city university graduate school of medicine
Institute
Department
Personal name
Funding Source
Organization
Yokohama city university graduate school of medicine
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Japan
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
横浜市立大学附属病院（神奈川県）、横浜市立大学附属市民総合医療センター（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 12 | Month | 02 | 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
| 2005 | Year | 01 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2005 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 12 | Month | 02 | Day |
Last modified on
| 2010 | Year | 12 | Month | 02 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003261
