UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000042042 |
|---|---|
| Receipt number | R000047964 |
| Scientific Title | Consideration on the relation between the removal efficiency of levetiracetam and the clinical presentation by the difference in the dialysis treatment conditions |
| Date of disclosure of the study information | 2020/11/01 |
| Last modified on | 2023/10/11 12:39:40 |
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Basic information
Public title
Consideration on the relation between the removal efficiency of levetiracetam and the clinical presentation by the difference in the dialysis treatment conditions
Acronym
Consideration on the relation between the removal efficiency of levetiracetam and the clinical presentation by the difference in the dialysis treatment conditions
Scientific Title
Consideration on the relation between the removal efficiency of levetiracetam and the clinical presentation by the difference in the dialysis treatment conditions
Scientific Title:Acronym
Consideration on the relation between the removal efficiency of levetiracetam and the clinical presentation by the difference in the dialysis treatment conditions
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
REBECHIRASETAMU removal efficiency by each dialysis treatment condition and the relation with the clinical presentation including a side effect are estimated
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Assessment
Primary outcomes
REBECHIRASETAMU blood level From change in dialysis method, 4 weeks later
Key secondary outcomes
Drowsiness by VAS and the score of the appetite From change in dialysis method, 4 weeks later
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Pre-dilution Online HDF (replacement amount 60L)Post dilution Online HDF (replacement amount 10L)Hemodialysis (HD) 4 weeks for each Dialysis number of times 12 times for each
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
The patient I do REBECHIRASETAMU internal use of
Key exclusion criteria
The present dialysis treatment condition is a patient besides Pre-dilution On-line HDF
A sleeping pill and a Antipsychotic taking medication regularly
The patient who can't get consent in study participation
The patient who judged that a doctor was improper in study participation
Target sample size
5
Research contact person
Name of lead principal investigator
| 1st name | Masanori |
| Middle name | |
| Last name | Isoda |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Clinical engineering operator
Zip code
770-0011
Address
1-39 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
TEL
088-631-0110
maisoda615@khg.or.jp
Public contact
Name of contact person
| 1st name | Masanori |
| Middle name | |
| Last name | Isoda |
Organization
Social medical corporation Kawashimakai Kawashima Hospital
Division name
Clinical engineering operator
Zip code
770-0011
Address
1-39 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
TEL
088-631-0110
Homepage URL
maisoda615@khg.or.jp
Sponsor or person
Institute
Social medical corporation Kawashimakai Kawashima Hospital
Institute
Department
Personal name
Funding Source
Organization
Social medical corporation Kawashimakai Kawashima Hospital
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
Social medical corporation Kawashimakai Kawashima Hospital
Address
1-39 Kitasako 1bancho, Tokushima City, Tokushima Prefecture
Tel
088-631-0110
maisoda615@khg.or.jp
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
| 2020 | 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
Completed
Date of protocol fixation
| 2020 | Year | 07 | Month | 27 | Day |
Date of IRB
| 2020 | Year | 09 | Month | 01 | Day |
Anticipated trial start date
| 2020 | Year | 11 | Month | 09 | Day |
Last follow-up date
| 2021 | Year | 02 | Month | 08 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 10 | Month | 07 | Day |
Last modified on
| 2023 | Year | 10 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000047964
| 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 |
