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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000032990
Receipt No. R000037619
Scientific Title Verification of nutrient retention effect by using anti-thrombotic PMMA membrane
Date of disclosure of the study information 2018/07/30
Last modified on 2018/08/29

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Basic information
Public title Verification of nutrient retention effect by using anti-thrombotic PMMA membrane
Acronym Venus study
Scientific Title Verification of nutrient retention effect by using anti-thrombotic PMMA membrane
Scientific Title:Acronym 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
1st name
Middle name
Last name Ikuto Masakane
Organization Honcho Yabuki Clinic
Division name Internal Medicine
Zip code
Address 1-6-17 Honcho,Yamagata
TEL 023-615-1877
Email Imasakan.aipod@seieig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiho Esashi
Organization Yabuki Hospital
Division name Clinical engineer
Zip code
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)

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
2018 Year 07 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 10 Month 28 Day
Date of IRB
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

Other
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

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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