UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008822 |
|---|---|
| Receipt number | 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 15:54:55 |
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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
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
sanko.honbu@earth.ocn.ne.jp
Sponsor or person
Institute
Keneikai sankou hospital engineer unit
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010367
| 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 |
