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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000008822
Receipt No. R000010367
Scientific Title Comparsion of the biocompatibility dialyzer ; AM69 mebrane(Gambro CO.,LTD) VS. polysulfone mebrane (Asahi medical CO.,LTD).
Date of disclosure of the study information 2012/09/02
Last modified on 2016/03/31

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Basic information
Public title Comparsion of the biocompatibility dialyzer ; AM69 mebrane(Gambro CO.,LTD) VS. polysulfone mebrane (Asahi medical CO.,LTD).
Acronym Comparison of the biocompatibility between AN69 mebrare and polysulfon mebrare.
Scientific Title Comparsion of the biocompatibility dialyzer ; AM69 mebrane(Gambro CO.,LTD) VS. polysulfone mebrane (Asahi medical CO.,LTD).
Scientific Title:Acronym Comparison of the biocompatibility between AN69 mebrare and polysulfon mebrare.
Region
Japan

Condition
Condition Chronic kidney disease
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Comparison of the biocompatibility of a dialyzer
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Phase I

Assessment
Primary outcomes White blood count
The number of blood platelets
Beta-thromboglobulin
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Device,equipment
Interventions/Control_1 Blood data sampling when using PS membrane dialyzer
Data sampling after 2 weeks washout period blood dialyzer change stacked
Interventions/Control_2
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
99 years-old >=
Gender Male and Female
Key inclusion criteria Maintenance hemodialysis patients.
Patients using the PS membrane dialyzer.
Patients with blood clotting occurs in the dialyzer and blood circuit.
Patients who do not improve after increasing an anti-clotting drug.
Key exclusion criteria Case of minors subject.
If it is determined objectively and not be able to give informed consent subjects valid for any reason.
Target sample size 6

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yuuji takeda
Organization Keneikai sankou hospital
Division name Engineer unit
Zip code
Address sanko.honbu@earth.ocn.ne.jp
TEL 075-676-0001
Email sanko.honbu@earth.ocn.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yuuji takeda
Organization Keneikai sankou hospital
Division name Engineer unit
Zip code
Address 3-6, Nomi-cho, Takatsuki ctiy, Osaka
TEL 075-676-0001
Homepage URL
Email sanko.honbu@earth.ocn.ne.jp

Sponsor
Institute Keneikai sankou hospital engineer unit
Institute
Department

Funding Source
Organization None
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

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 健栄会三康病院(大阪府)、健栄会三康病院附属診療所(大阪府)、健栄会三康クリニック(大阪府)、三康診療所(大阪府)

Other administrative information
Date of disclosure of the study information
2012 Year 09 Month 02 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 Terminated
Date of protocol fixation
2012 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date
2012 Year 06 Month 01 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
2012 Year 08 Month 31 Day
Last modified on
2016 Year 03 Month 31 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010367

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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