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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001275
Receipt No. R000001552
Scientific Title Clinical efficacy of high-flux polysulfone dialyzer, FX-S
Date of disclosure of the study information 2008/07/29
Last modified on 2014/09/29

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Basic information
Public title Clinical efficacy of high-flux polysulfone dialyzer, FX-S
Acronym Clinical efficacy of FX-S
Scientific Title Clinical efficacy of high-flux polysulfone dialyzer, FX-S
Scientific Title:Acronym Clinical efficacy of FX-S
Region
Japan

Condition
Condition hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 High prevalent of CVD and HD-related complications in HD patients are closely associated with clinical outcome and morbidity. Sufficient removal of uremic toxin per se by dialysis using biocompatible dialyzer is important in those patients. Recently a new class of dialyzer with increased performance and outstanding biocompatibility was developed. The purpose of the present study is to estimate function and efficacy of new dialyzer compared with the classical routinely used high-flux polysulfone
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes At baseline, 3 months and 6 months, parameters of lipid, inflammation and oxidative stress
Key secondary outcomes effectiveness for anemia and nutrition

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -but assessor(s) are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Type 5 high-flux polysulfone (PS) dialyzer (FX-S)
Interventions/Control_2 Type 4 PS dialyzer (FX)
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 All recruited patients underwent routine conventional bicarbonate HD three times a week (3 - 4 hours per session) using standard high-flux polysulfone (PS), and fully informed consent was obtained.
Key exclusion criteria Patients with clinical signs of overt infection, acute vasculitis, or liver disease at the time of recruitment were excluded. So that lipid metabolism could be evaluated, patients taking lipid-lowering drugs such as statins, fibrates, ezetimibe, or ethyl icosapentate were also excluded from the study
Target sample size 40

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Tadao Akizawa
Organization Showa University School of Medicine
Division name Division of Nephrology , Depertment of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku,142-8666, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University School of Medicine
Division name Division of Nephrology Department of Internal Medicine
Zip code
Address
TEL
Homepage URL
Email hondah@med.showa-u.ac.jp

Sponsor
Institute Division of Nephrology Department of Internal Medicine Showa University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology Department of Internal Medicine Showa University School of Medicine
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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
2008 Year 07 Month 29 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
2008 Year 05 Month 10 Day
Date of IRB
Anticipated trial start date
2008 Year 08 Month 01 Day
Last follow-up date
2009 Year 12 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 07 Month 29 Day
Last modified on
2014 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001552

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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