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Recruitment status Completed
Unique ID issued by UMIN UMIN000011764
Receipt No. 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

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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.

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

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

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

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
Middle name
Last name Tsuji
Organization National Defense Medical College Hospital
Division name Department of Blood Purification
Zip code
Address 3-2 Namiki, Tokorozawa Saitma, Japan
TEL 04-2995-1511
Email futebol@ndmc.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Ishizeki
Organization National Defense Medical College Hospital
Division name Department of Blood Purification
Zip code
Address 3-2 Namiki, Tokorozawa Saitma, Japan
TEL 04-2995-1511
Homepage URL
Email halfmoon@ndmc.ac.jp

Sponsor
Institute National Defense Medical College
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and
report of the research including funding management. It doesn't mean
funding agency". Therefore, all clinical trial should have the one.

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013756


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