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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000000963
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Yoshihiko Saito
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001160

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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