UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects
Title of the study (Brief title)	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

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	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

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	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	Shoichi Uemura
Organization	Bousei Kannai Clinic
Division name	Bousei Kannai Clinic
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	Shoichi Uemura
Organization	Bousei Kannai Clinic
Division name	Bousei Kannai Clinic
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

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	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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 02 Month 16 Day
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

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Publication of results	Unpublished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