UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of nutrient retention effect by using anti-thrombotic PMMA membrane
Title of the study (Brief title)	Venus study
Region	Japan

Condition
Condition	Chronic Renal Failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	We verify that PMMA membrane with improved anti-thrombogenicity is useful to nutritional condition in dialysis patients.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mal-nutrition Inflammation Score(MIS) and its evaluated items
Key secondary outcomes	Dry weight,nPCR,%CGR,Arm circumference,CRP,unidentified complaints

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Cluster
Blinding	Open -no one is 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	Use of FILTRYZER NF
Interventions/Control_2	Use of polysulfone-type femodialyzers
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	70 years-old <=
Age-upper limit	90 years-old >
Gender	Male and Female
Key inclusion criteria	- Patients who are more than 70 year old and receive maintain hemodialysis therapy 3 times a week - Patients who are treated with polysulfone type hemodialyzers excluding VPS and NV. - Patiente without urinary symptoms
Key exclusion criteria	- Serum albumin levels are less than 3.0g/dL. - Patients who had an event in the field of brain heart within past 3 months - Patients who has clear inflammatory diseases - Patients who has clear and active infection diseases - Elderly patients who are more than 90 years old or can't walk by themselves
Target sample size	100

Research contact person
Name of lead principal investigator	Ikuto Masakane
Organization	Honcho Yabuki Clinic
Division name	Internal Medicine
Address	1-6-17 Honcho,Yamagata
TEL	023-615-1877
Email	Imasakan.aipod@seieig.or.jp

Public contact
Name of contact person	Shiho Esashi
Organization	Yabuki Hospital
Division name	Clinical engineer
Address	4-5-5 Shimakita,Yamagata
TEL	023-682-8566
Homepage URL
Email	esashi@seieig.or.jp

Sponsor
Institute	Yabuki Hospital
Institute
Department

Funding Source
Organization	Toray Industries,Inc
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Tendo Onsen Yabuki Clinic Honma Hospital Shonai Hospital Nagaoka Clinic Matsushita Clinic Hanazono Hospital Sanai Hospital Kitaasaka Ekimae Clinic Amano Clinic Koga Hospital 21
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

Other administrative information
Date of disclosure of the study information	2018 Year 07 Month 30 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 28 Day
Anticipated trial start date	2015 Year 11 Month 10 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	2018 Year 06 Month 14 Day
Last modified on	2018 Year 08 Month 29 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037619