UMIN-CTR Clinical Trial

Basic information
Public title	NV membrane can Improve the Tendency of Oxidative Stress during HD, Preliminary Study
Acronym	NVITOS Preliminary Study
Scientific Title	NV membrane can Improve the Tendency of Oxidative Stress during HD, Preliminary Study
Scientific Title:Acronym	NVITOS Preliminary Study
Region	Japan

Condition
Condition	Hemodialysis
Classification by specialty	Medicine in general Endocrinology and Metabolism Nephrology Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Reduction inspects blood oxidation stress markers or inflammatory markers level by using NV whether possible.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Use NV dialyzer and conventional polysulfone dialyzer and compare the blood marker levels. Measurement marker Plasma free radical IL-6 Pentraxin 3 Fetuin A High sensitive CRP Homocysteine Pentosidine
Key secondary outcomes

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	Change from using conventional polysulfone dialyzer to using good biocompatibility dialyzer(NV) (for 6 months).
Interventions/Control_2	Change from using good biocompatibility dialyzer(NV) to using conventional polysulfone dialyzer (for 6 months).
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	1) The patients whose age is between 20 and 80 years at the time of enrollment in this study. 2) The patients who are using polysulfone dialyzers (NV or except NV).
Key exclusion criteria	1) A patient who is treated with other renal insufficiency therapies, continuous ambulatory peritoneal dialysis and hemodiafiltration, excluding hemodialysis. 2) A patient who is enrolled to other clinical study. 3) Cancer bearing patients. 4) A patient who has anamnestic cardiovascular diseases (heart attack, stroke) in less than 3 months. 5) A patient who is consider as onset of acute inflammation. 6) A patient who is a pregnant or intends to become a pregnant within one year. 8) A patient who is judged as the inadequate subject of this study by the doctor.
Target sample size	8

Research contact person
Name of lead principal investigator	1st name Middle name Last name Tadashi Tomo
Organization	Oita university hospital
Division name	Blood Purification Center
Zip code
Address	879-5593 Idai-gaoka, 1-1, Hasama-machi, Yufu-city, Oita, Japan
TEL	097-549-5804
Email	tomo@oita-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Kaede Ishida
Organization	Oita university hospital
Division name	Blood Purification Center
Zip code
Address	879-5593 Idai-gaoka, 1-1, Hasama-machi, Yufu-city, Oita, Japan
TEL	097-549-5804
Homepage URL
Email	Kaede-m-06@oita-u.ac.jp

Sponsor
Institute	Oita university hospital Blood Purification Center
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
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	医療法人社団　顕腎会大分内科クリニック（大分県）

Other administrative information
Date of disclosure of the study information	2013 Year 11 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	2013 Year 11 Month 30 Day
Date of IRB
Anticipated trial start date	2013 Year 12 Month 01 Day
Last follow-up date	2014 Year 09 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2013 Year 11 Month 30 Day
Last modified on	2017 Year 12 Month 05 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000014222

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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