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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000017273
Receipt No. R000020039
Scientific Title Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects
Date of disclosure of the study information 2015/04/30
Last modified on 2016/06/27

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Basic information
Public title Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects
Acronym VASCPREDICT_Study
Scientific Title Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects
Scientific Title:Acronym VASCPREDICT_Study
Region
Japan

Condition
Condition Chronic maintenance hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Malignancy
Genomic information NO

Objectives
Narrative objectives1 It is examined whether there are the correlations between plasma sCD40L concentration before and after dialysis and PRR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Correlation between concentration of plasma sCD40L and PRR during dialysis.
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 Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 Hemodialysis therapy with polysulfone type dialyzer.
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 1)A patient who are continuously treated with three 4-h dialysis sessions per week using polysulfone type dialyzer.
2)A patient whose age is more than 20 years old when he/she is enrolled.
3)A patient whose dialysis vintage is more then 1 year when he is enrolled.
4)A patient that vascular access is an arter iovenous fistula.
Key exclusion criteria 1)A patient who has been treated with the renal replacement therapies other than hemodialysis 1 year before.
2)A patient who has the comorbidities including malignant tumor,liver disease,hematologic disease and gastrointestinal hemorrhage when he/she is enrolled.
3))A patient who is pregnant or intends to be pregnant within the period of study.
4))A patient who is judged inadequate by participating physicians.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Shoichi Uemura
Organization Bousei Kannai Clinic
Division name Bousei Kannai Clinic
Zip code
Address 9F Yokohama Oodori Kouen Bldg.2-4-1 Hourai-cho, Naka-ku,Yokohama city,Kanagawa
TEL 045-243-5711
Email showak04@eagle.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shoichi Uemura
Organization Bousei Kannai Clinic
Division name Bousei Kannai Clinic
Zip code
Address 9F Yokohama Oodori Kouen Bldg.2-4-1 Hourai-cho, Naka-ku,Yokohama city,Kanagawa
TEL 045-243-5711
Homepage URL
Email showak04@eagle.ocn.ne.jp

Sponsor
Institute Bousei Kannai Clinic
Institute
Department

Funding Source
Organization TORAY INDUXTRIES Inc.
Organization
Division
Category of Funding Organization Profit organization
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 松和会 望星関内クリニック

Other administrative information
Date of disclosure of the study information
2015 Year 04 Month 30 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 02 Month 16 Day
Date of IRB
Anticipated trial start date
2015 Year 04 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2015 Year 04 Month 25 Day
Last modified on
2016 Year 06 Month 27 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020039

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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