UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000012449
Receipt No. R000014222
Scientific Title NV membrane can Improve the Tendency of Oxidative Stress during HD, Preliminary Study
Date of disclosure of the study information 2013/11/30
Last modified on 2017/12/05

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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


Contact us.