UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011764 |
|---|---|
| Receipt number | R000013756 |
| Scientific Title | Clinical effects of polysulfone membrane, NV-13U |
| Date of disclosure of the study information | 2013/09/17 |
| Last modified on | 2019/10/01 13:49:36 |
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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
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
halfmoon@ndmc.ac.jp
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013756
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