UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000032990
Receipt number 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 16:27:35

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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 or person

Institute

Yabuki Hospital

Institute

Department

Personal name



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

Value
https://center6.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