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Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000014781
Receipt No. R000017186
Official scientific title of the study 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 2018/08/09

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Basic information
Official scientific title of the study The Effect on methemoglobin content of hemodialysis patients with vitamin E-bonded polysulfone membrane dialyzer.
Title of the study (Brief title) 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

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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 &beta;2MG adsorption column
Target sample size 50

Research contact person
Name of lead principal investigator Takashi Yasuda
Organization Matsushita Memorial Hospital
Division name Department of Nephrology and artificial kidney
Address 5-55 Sotojima-cho,Moriguchi-city, Osaka 570-8540,Japan
TEL 06-6991-1231
Email yasuda.takashi001@jp.panasonic.com

Public contact
Name of contact person Takashi Yasuda
Organization Matsushita Memorial Hospital
Division name Department of Nephrology and artificial kidney
Address 5-55 Sotojima-cho,Moriguchi- city, Osaka 570-8540,Japan
TEL 06-6991-1231
Homepage URL
Email yasuda.takashi001@jp.panasonic.com

Sponsor
Institute Matsushita Memorial Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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)

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

Progress
Recruitment status Enrolling by invitation
Date of protocol fixation
2014 Year 03 Month 13 Day
Anticipated trial start date
2014 Year 09 Month 01 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results Unpublished
URL releasing results
Results
Other related information

Management information
Registered date
2014 Year 08 Month 06 Day
Last modified on
2018 Year 08 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017186


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