UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014781 |
|---|---|
| Receipt number | R000017186 |
| Scientific Title | The Effect on methemoglobin content of hemodialysis patients with vitamin E-bonded polysulfone membrane dialyzer. |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2019/03/13 13:14:40 |
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Basic information
Public title
The Effect on methemoglobin content of hemodialysis patients with vitamin E-bonded polysulfone membrane dialyzer.
Acronym
The Effect on methemoglobin content of hemodialysis patients with vitamin E-bonded polysulfone membrane dialyzer.
Scientific Title
The Effect on methemoglobin content of hemodialysis patients with vitamin E-bonded polysulfone membrane dialyzer.
Scientific Title:Acronym
The Effect on methemoglobin content of hemodialysis patients with vitamin E-bonded polysulfone membrane dialyzer.
Region
| Japan |
Condition
Condition
CKD/ESRD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
For the maintenance dialysis patient, it is predicted that enhanced oxidative stress by dialysis-operation leads various complications. In particular, it is considered the oxidization of RBC as a cause of a dialysis patient´s anemia. It is possible to suppress the oxidation on RBC during hemodialysis with vitamin E-coated dialyzer ¨VPS-HA¨. The aim of this research is to examine the validity about anti-oxidative performance of hemodialysis with a vitamin E-coated dialyzer ¨VPS-HA¨.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
methemoglobin
Key secondary outcomes
CBS,Fib,TAT,CVD event,
PTH-IN,Hs-CRP,AOPP,
redox state of human serum albumin,MDA-LDL,vitamin E,vitamin C
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
YES
Institution consideration
Blocking
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
VitaminE coated dialyzer
Interventions/Control_2
Non VitaminE coated dialyzer
(APS-MD New)
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
Adult human undergoing chronic dialysis therapy
Key exclusion criteria
Administration of supplement(VitC,VitE)
Existence of criticalcardiovascular complications
HDF therapy or Use of β2MG adsorption column
Target sample size
50
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Yasuda |
Organization
Matsushita Memorial Hospital
Division name
Department of Nephrology and artificial kidney
Zip code
Address
5-55 Sotojima-cho,Moriguchi-city, Osaka 570-8540,Japan
TEL
06-6991-1231
yasuda.takashi001@jp.panasonic.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Yasuda |
Organization
Matsushita Memorial Hospital
Division name
Department of Nephrology and artificial kidney
Zip code
Address
5-55 Sotojima-cho,Moriguchi- city, Osaka 570-8540,Japan
TEL
06-6991-1231
Homepage URL
yasuda.takashi001@jp.panasonic.com
Sponsor or person
Institute
Matsushita Memorial Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahi Kasei Medical Co.,Ltd
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
パナソニック健康保険組合 松下記念病院（大阪府） Matsushita Memorial Hospital (Osaka)
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 09 | 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
22
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
| 2014 | Year | 03 | Month | 13 | Day |
Date of IRB
| 2014 | Year | 03 | Month | 13 | Day |
Anticipated trial start date
| 2014 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 08 | Month | 06 | Day |
Last modified on
| 2019 | Year | 03 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017186
