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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000030628
Receipt No. R000034954
Scientific Title Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U"
Date of disclosure of the study information 2017/12/28
Last modified on 2018/10/03

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Basic information
Public title Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U"
Acronym "NF-U"trial
Scientific Title Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U"
Scientific Title:Acronym "NF-U"trial
Region
Japan

Condition
Condition End-stage renal disease requiring homodialysis
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 EVAL,NF-U and PS Performance comparison
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Using EVAL,NF,PS,compare albumin leakage.
Speculation
Albumin leakage :EVAL>NF-U=PS
Amino acid leakage :PS>NF-U=EVAL
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 3
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Dialyzers will be changed to the PMMA dialyzer'NF-U'.
Interventions/Control_2 EVAL dialyzer is continued and used
Interventions/Control_3 PS dialyzer is continued and used
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 The patients whose age is over 20 years at the time of enrollment in this study.
Key exclusion criteria A patient who is judged as the inadequate subject of this study by the doctor.
Target sample size 18

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kzue Ueki
Organization Toho Hospital
Division name Kidney dialysis senter
Zip code
Address 1155 Azami Ksakakemachi midorishi gunmaken
TEL 0277-76-6311
Email kueki@toho-hp.jp

Public contact
Name of contact person
1st name
Middle name
Last name Masaki Matsumura
Organization Toho Hospital
Division name Kidney dialysis senter
Zip code
Address 1155 Azami Ksakakemachi midorishi gunmaken
TEL 0277-76-6311
Homepage URL
Email me6341mm@toho-hp.jp

Sponsor
Institute Toho Hospital
Institute
Department

Funding Source
Organization Toray Medical
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

Other administrative information
Date of disclosure of the study information
2017 Year 12 Month 28 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
2017 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2017 Year 07 Month 01 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
2018 Year 04 Month 15 Day
Date trial data considered complete
2018 Year 04 Month 30 Day
Date analysis concluded
2018 Year 04 Month 30 Day

Other
Other related information

Management information
Registered date
2017 Year 12 Month 28 Day
Last modified on
2018 Year 10 Month 03 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034954

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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