UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019455 |
|---|---|
| Receipt number | R000022487 |
| Scientific Title | Study of the Influenza vaccine immune response using PMMA dialyzer. |
| Date of disclosure of the study information | 2015/10/26 |
| Last modified on | 2018/04/23 16:56:51 |
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Basic information
Public title
Study of the Influenza vaccine immune response using PMMA dialyzer.
Acronym
Influenza vaccine effectiveness in using PMMA dialyzer
Scientific Title
Study of the Influenza vaccine immune response using PMMA dialyzer.
Scientific Title:Acronym
Influenza vaccine effectiveness in using PMMA dialyzer
Region
| Japan |
Condition
Condition
End-stage renal disease requiring hemodialysis
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Acquisition influenza immunization
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Improvement of immune responsiveness at 6 months after conversiton to PMMA dialyzer
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
| Device,equipment |
Interventions/Control_1
Dialyzers will be chnaged to the PMMA dialyzers, on patients who was made immunity to influenza vaccination.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patients whose age is over 20 years at the time of enrollment in this study.
Key exclusion criteria
A patient who is judged as the inadequate subject of this study by the doctor.
Target sample size
120
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadashi Tomo |
Organization
Oita university hospital
Division name
Blood purfication center
Zip code
Address
Idai-gaoka,1-1, Hasama-machi, Yufu-city, Oita,Japan
TEL
097-586-6741
tomo@oita-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadashi Tomo |
Organization
Oita university hospital
Division name
Blood purfication center
Zip code
Address
Idai-gaoka,1-1, Hasama-machi, Yufu-city, Oita,Japan
TEL
097-586-6741
Homepage URL
tomo@oita-u.ac.jp
Sponsor or person
Institute
Oita University Hospital
Blood purification center
Institute
Department
Personal name
Funding Source
Organization
Toray Industories Inc.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Other related organizations
Co-sponsor
Oita Naika Clinic
Matsuyama Iin
Oita Nakamura Hospital
Suwanomoriori Hospital
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
| 2015 | Year | 10 | Month | 26 | 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
| 2015 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 26 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2017 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 01 | Month | 09 | Day |
Date analysis concluded
| 2018 | Year | 01 | Month | 09 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 10 | Month | 22 | Day |
Last modified on
| 2018 | Year | 04 | Month | 23 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022487
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
