UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010743 |
|---|---|
| Receipt number | 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 21:02:49 |
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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
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
ideken@hiroshima-u.ac.jp
Sponsor or person
Institute
Trasnplantation surgery, Hiroshima University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012084
