UMIN-CTR Clinical Trial

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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