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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000024955
Receipt No. R000028706
Scientific Title Characteristics and Clinical Evaluation of PMMA Dialyzer "NF-PQ" (made by Toray Industries, Inc.)
Date of disclosure of the study information 2016/11/22
Last modified on 2018/09/29

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Basic information
Public title Characteristics and Clinical Evaluation of PMMA Dialyzer "NF-PQ" (made by Toray Industries, Inc.)
Acronym Characteristics and Clinical Evaluation of PMMA Dialyzer "NF-PQ" (made by Toray Industries, Inc.)
Scientific Title Characteristics and Clinical Evaluation of PMMA Dialyzer "NF-PQ" (made by Toray Industries, Inc.)
Scientific Title:Acronym Characteristics and Clinical Evaluation of PMMA Dialyzer "NF-PQ" (made by Toray Industries, Inc.)
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 We verify the clinical usefulness of new PMMA dialyzer with improved hemocompatibility for hemodialysis patients.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes ・Property of solute removal (Non-inferiority)
・Changes in platelet count during dialysis (Improvement)
Key secondary outcomes ・Peripheral circulation and some dialysis-related complaints (Influence)

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 Group 1: Dialyzer was changed to new PMMA membrane "NF" during three months, and changed to conventional PMMA membrane "BG" during three months.
Interventions/Control_2 Group 2: Dialyzer was changed to conventional PMMA membrane "BG" during three months, and changed to new PMMA membrane "NF" during three 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

Not applicable
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria ・Patient with maintenance hemodialysis therapy
・Patient using PMMA membrane
Key exclusion criteria ・With an active infection clearly
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Ikuto Masakane
Organization Yabuki Hospital
Division name Deputy director
Zip code
Address 4-5-5 Shima kita, Yamagata, Yamagata
TEL 023-682-8566
Email Imasakan.aipod@seieig.or.jp

Public contact
Name of contact person
1st name
Middle name
Last name Shiho Esashi
Organization Yabuki Hospital
Division name Clinical engineer
Zip code
Address 4-5-5 Shima kita, Yamagata, Yamagata
TEL 023-682-8566
Homepage URL
Email esashi@seieig.or.jp

Sponsor
Institute Yabuki Hospital
Institute
Department

Funding Source
Organization Toray Industries, Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor Honcho Yabuki Clinic
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
2016 Year 11 Month 22 Day

Related information
URL releasing protocol
Publication of results Partially published

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
2012 Year 10 Month 25 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 26 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 11 Month 22 Day
Last modified on
2018 Year 09 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028706

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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