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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010743
Receipt No. R000012084
Scientific Title Analysis of immunological status using CFSE-MLR for de-novo kidney transplant recipients who are treated with Everolimus commencing 3 months after surgery.
Date of disclosure of the study information 2013/05/16
Last modified on 2020/03/11

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Basic information
Public title Analysis of immunological status using CFSE-MLR for de-novo kidney transplant recipients who are treated with Everolimus commencing 3 months after surgery.
Acronym Analysis of immunological status using CFSE-MLR for kidney transplant recipients treated with Everolimus.
Scientific Title Analysis of immunological status using CFSE-MLR for de-novo kidney transplant recipients who are treated with Everolimus commencing 3 months after surgery.
Scientific Title:Acronym Analysis of immunological status using CFSE-MLR for kidney transplant recipients treated with Everolimus.
Region
Japan

Condition
Condition After kidney transplantation
Classification by specialty
Surgery in general
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Exploratory study of analysis of immunological status using CFSE-MLR for kidney transplant recipients treated with reduced Cyclosporine plus Everolimus.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Comparison of CFSE-MLR categorization between reduced Cyclosporine plus Everolimus group and normal dose Cyclosporine group.
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Cluster
Blinding Open -no one is blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is considered as adjustment factor in dynamic allocation.
Blocking YES
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Reduced Cyclosporine plus Everolimus treatment
Interventions/Control_2 Normal dose Cyclosporine
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
70 years-old >=
Gender Male and Female
Key inclusion criteria de-novo kidney transplant recipients
Key exclusion criteria rejection
severe proteinuria
Target sample size 20

Research contact person
Name of lead principal investigator
1st name Hideki
Middle name
Last name Ohdan
Organization Hiroshima University Hospital
Division name Trasnplantation surgery
Zip code 734-8551
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 0822575222
Email hohdan@hiroshima-u.ac.jp

Public contact
Name of contact person
1st name Kentaro
Middle name
Last name Ide
Organization Hiroshima University Hospital
Division name Trasnplantation surgery
Zip code 734-8551
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
TEL 082-257-5222
Homepage URL
Email ideken@hiroshima-u.ac.jp

Sponsor
Institute Trasnplantation surgery, Hiroshima University Hospital
Institute
Department

Funding Source
Organization Trasnplantation surgery, Hiroshima University Hospital
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 Center for Integrated Medical Research
Address 1-2-3, Kasumi, Minami-ku, Hiroshima
Tel 082-257-1752
Email protocol@cimr.hiroshima-u.ac.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
2013 Year 05 Month 16 Day

Related information
URL releasing protocol None
Publication of results Unpublished

Result
URL related to results and publications None
Number of participants that the trial has enrolled 80
Results
No significant difference was found between reduced Cyclosporine plus Everolimus group and normal dose Cyclosporine group in CFSE-MLR categorization.
Results date posted
2020 Year 03 Month 11 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
After kidney transplantation
Participant flow
Parallel
Randomized
Open -no one is blinded
Adverse events
Hyperlipidemia etc.
Outcome measures
Comparison of CFSE-MLR categorization between reduced Cyclosporine plus Everolimus group and normal dose Cyclosporine group.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2013 Year 03 Month 26 Day
Date of IRB
2013 Year 05 Month 15 Day
Anticipated trial start date
2013 Year 05 Month 15 Day
Last follow-up date
2017 Year 06 Month 30 Day
Date of closure to data entry
2017 Year 06 Month 30 Day
Date trial data considered complete
2017 Year 06 Month 30 Day
Date analysis concluded
2017 Year 06 Month 30 Day

Other
Other related information

Management information
Registered date
2013 Year 05 Month 16 Day
Last modified on
2020 Year 03 Month 11 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012084

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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