UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000963 |
|---|---|
| Receipt number | R000001160 |
| Scientific Title | Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome |
| Date of disclosure of the study information | 2010/01/01 |
| Last modified on | 2017/07/11 18:03:24 |
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Basic information
Public title
Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome
Acronym
Cyclosporine for MCNS
Scientific Title
Efficacy and safety of cyclosporine and steroid for the treatment of minimal change nephrotic syndrome
Scientific Title:Acronym
Cyclosporine for MCNS
Region
| Japan |
Condition
Condition
Minimal change nephrotic syndrome
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and efficacy of cyclosporine for the patients with MCNS
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Rate for complete remission
Total dose of steroid
Duration of admission
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
administration of cyclosporine
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
MCNS patients proven by renal biopsy
Key exclusion criteria
Cr>=2.0mg/dl or eGFR<50
Malignancy
Uncontrolled hypertension
Seizure disorder
Pregnant women
Infection
Severe cardiac, hepatic or pancreatic disease
Alelrgy to cyclosporine
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Saito |
Organization
Nara Medical University
Division name
1st Dept Intern Med
Zip code
Address
840 Shijo, Kasihara Nara
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Nara Medical University
Division name
1st Dept Intern Med
Zip code
Address
TEL
0744-22-3051
Homepage URL
Sponsor or person
Institute
Yoshihiko Saito
Institute
Department
Personal name
Funding Source
Organization
Self funding
Organization
Division
Category of Funding Organization
Self funding
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
| 2010 | Year | 01 | 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
Completed
Date of protocol fixation
| 2007 | Year | 09 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 01 | Month | 03 | Day |
Last modified on
| 2017 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001160
