UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U"
Title of the study (Brief title)	"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	Kzue Ueki
Organization	Toho Hospital
Division name	Kidney dialysis senter
Address	1155 Azami Ksakakemachi midorishi gunmaken
TEL	0277-76-6311
Email	kueki@toho-hp.jp

Public contact
Name of contact person	Masaki Matsumura
Organization	Toho Hospital
Division name	Kidney dialysis senter
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2017 Year 07 Month 01 Day
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

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Publication of results	Unpublished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