UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000004486 |
|---|---|
| Receipt number | R000005367 |
| Scientific Title | The efficacy of AN69 membrane for elimination of aminoglycoside. |
| Date of disclosure of the study information | 2010/11/01 |
| Last modified on | 2010/11/01 13:04:04 |
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Basic information
Public title
The efficacy of AN69 membrane for elimination of aminoglycoside.
Acronym
The efficacy of AN69 membrane for elimination of aminoglycoside.
Scientific Title
The efficacy of AN69 membrane for elimination of aminoglycoside.
Scientific Title:Acronym
The efficacy of AN69 membrane for elimination of aminoglycoside.
Region
| Japan |
Condition
Condition
MRSA infection
Classification by specialty
| Infectious disease |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Clinical efficacy of negative charged AN69 membrane will be investigated to use arbekacin in safety.
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change over time of blood concentration of arbekacin.
Key secondary outcomes
Calculation of pharmacokinetic parameters of arbekacin in hemodialysis patients using AN69 dialyzer.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Participants who administered 200mg of arbekacin are underwent hemodialysis using AN69 dialyzer, and their blood samples are assayed.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1) gave their or their relatives' written informed consent
2) age, 20 years or higher
3) patient who requires hemodialysis
4) MRSA infections, including suspicions
Key exclusion criteria
1) patients taking angiotensin-converting enzyme inhibitor.
2) patients having history of hypersensitivity to arbekacin.
3) patients having family with hearing loss.
4) patients being participating other study, and having participated other study within three months.
5) other situation that doctor decides.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirata Sumio |
Organization
Graduate school of Pharmaceutical Sciences, Kumamoto University
Division name
Division of Clinical Pharmacology
Zip code
Address
5-1 Oe-honmachi, Kumamoto
TEL
096-371-4856
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirata Sumio |
Organization
Graduate school of Pharmaceutical Sciences, Kumamoto University
Division name
Division of Clinical Pharmacology
Zip code
Address
5-1 Oe-honmachi, Kumamoto
TEL
096-371-4856
Homepage URL
Sponsor or person
Institute
Division of Clinical Pharmacology, Graduate school of Pharmaceutical Sciences, Kumamoto University
Institute
Department
Personal name
Funding Source
Organization
Graduate school of Pharmaceutical Sciences, Kumamoto University
Organization
Division
Category of Funding Organization
Other
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
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 11 | Month | 01 | 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
Open public recruiting
Date of protocol fixation
| 2010 | Year | 05 | Month | 13 | Day |
Date of IRB
Anticipated trial start date
| 2010 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2011 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2010 | Year | 11 | Month | 01 | Day |
Last modified on
| 2010 | Year | 11 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005367
