UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024955 |
|---|---|
| Receipt number | 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 15:46:28 |
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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
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
esashi@seieig.or.jp
Sponsor or person
Institute
Yabuki Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028706
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
