UMIN-CTR Clinical Trial

Basic information
Public title	Clinical effects of polysulfone membrane, NV-13U
Acronym	Clinical effects of polysulfone membrane, NV-13U
Scientific Title	Clinical effects of polysulfone membrane, NV-13U
Scientific Title:Acronym	Clinical effects of polysulfone membrane, NV-13U
Region	Japan

Condition
Condition	end-stage renal failure
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	High biocompatibility controlling that a platelet and protein attach to the film surface is important for the hemodialysis film. Biocompatibility is high in the polysulfone film, and the range of a material targeted for the removal in blood is high in the removal performance widely. However, it is a problem that the polysulfone film has many thrombopenia, adhesion of the white clot in the blood circuit. Therefore I raised a hydrophilicity, and biocompatible high polysulfone film "NV" indicating the high antithrombotic nature was released. We weigh clinical responses such as solute removal ability, the antithrombotic biocompatibility against NV with a conventional polysulfone film (APS) for hemodialysis patients. Valuable data are in this way provided in giving the safe hemodialysis treatment for the elderly patient.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	We use conventional polysulfone film (APS - 13SA) and new polysulfone film (NV- 13 U) in 4-week crossover for a hemodialysis patients twice. And we measure solute removal ability (clearance, quantity of removal, removal rate), antithrombotic (activated solidification time, solidification ability) and compare them.
Key secondary outcomes	We measure a very small amount of albumin in the biocompatible (leukocyte image) dialysis waste fluid of the polysulfone film (APS - 13SA) and new polysulfone film (NV- 13 U) and compare the safety for the elderly patient.

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Non-randomized
Randomization unit
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	four weeks of APS-13SA use, amd for two weeks of the washout period, and then four weeks of NV-13U use
Interventions/Control_2	four weeks of NV-13U use, and for two weeks of the washout period, and then four weeks of APS-13SA use
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	60 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	end-stage renal failure patients with stable outpatient maintenance hemodialysis 60 years or older
Key exclusion criteria	hemodialysis patients without any cancer or acute Inflammation
Target sample size	12

Research contact person
Name of lead principal investigator	1st name Akira Middle name Last name Tsuji
Organization	National Defense Medical College Hospital
Division name	Department of Blood Purification
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa Saitma, Japan
TEL	04-2995-1511
Email	futebol@ndmc.ac.jp

Public contact
Name of contact person	1st name Kaori Middle name Last name Ishizeki
Organization	National Defense Medical College Hospital
Division name	Department of Blood Purification
Zip code	359-8513
Address	3-2 Namiki, Tokorozawa Saitma, Japan
TEL	04-2995-1511
Homepage URL
Email	halfmoon@ndmc.ac.jp

Sponsor
Institute	National Defense Medical College
Institute
Department

Funding Source
Organization	Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization	Non profit foundation
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization	National Defense Medical College
Address	3-2 Namiki, Tokorozawa Saitma, Japan
Tel	04-2995-1511
Email	ins010@ndmc.ac.jp

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	防衛医科大学校病院（埼玉県）　National Defense Medical College Hospital (Saitama)

Other administrative information
Date of disclosure of the study information	2013 Year 09 Month 17 Day

Related information
URL releasing protocol
Publication of results	Published

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results	57th Congress of the Japanese Society for Dialysis therapy In NV, quantity of of alfa1-MG and Alb removal, the Alb leakage significantly showed a high price in comparison with APS, too. In addition, We did not recognize significant difference for a platelet activity marker, a system for solidification lines, a blood count result. Thus, attention may be necessary for clinical adaptation of NV for the elderly person.
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	2011 Year 10 Month 31 Day
Date of IRB
Anticipated trial start date	2011 Year 11 Month 21 Day
Last follow-up date	2012 Year 06 Month 10 Day
Date of closure to data entry	2012 Year 07 Month 30 Day
Date trial data considered complete	2013 Year 07 Month 30 Day
Date analysis concluded	2013 Year 09 Month 29 Day

Other
Other related information

Management information
Registered date	2013 Year 09 Month 14 Day
Last modified on	2019 Year 10 Month 01 Day

Link to view the page
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013756

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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