UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015787 |
|---|---|
| Receipt number | R000018368 |
| Scientific Title | Clinical evaluation of new biomarkers in diagnosis of valproate-induced renal tubular dysfunction. |
| Date of disclosure of the study information | 2014/12/01 |
| Last modified on | 2014/11/29 11:14:59 |
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Basic information
Public title
Clinical evaluation of new biomarkers in diagnosis of valproate-induced renal tubular dysfunction.
Acronym
Clinical evaluation of new biomarkers in diagnosis of valproate-induced renal tubular dysfunction.
Scientific Title
Clinical evaluation of new biomarkers in diagnosis of valproate-induced renal tubular dysfunction.
Scientific Title:Acronym
Clinical evaluation of new biomarkers in diagnosis of valproate-induced renal tubular dysfunction.
Region
| Japan |
Condition
Condition
Epilepsy
Classification by specialty
| Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate a most sensitive biomarker for diagnosis of valproate-induced renal dysfunction.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
L-FABP(L-type fatty acid binding protein) could be a most sensitive biomarker for diagnosis of valproate-induced renal dysfunction.
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
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Diagnosis
Type of intervention
| Medicine |
Interventions/Control_1
Epilepsy patients treated with valproate and whom treated with anti-epileptic drugs except for valproate.
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
| 1 | years-old | <= |
Age-upper limit
| 50 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
The patients treated with valproate for more than 3 months.
Key exclusion criteria
The patients with renal diseases.
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Atsushi Araki |
Organization
Kansai medical university
Division name
Department of Pediatrics
Zip code
Address
10-15 Fumizono-cho, Moriguchi-shi, Osaka, Japan
TEL
06-6992-1001
araki@takii.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Atsushi Araki |
Organization
Kansai medical university
Division name
Department of Pediatrics
Zip code
Address
10-15 Fumizono-cho, Moriguchi-shi, Osaka, Japan
TEL
06-6992-1001
Homepage URL
araki@takii.kmu.ac.jp
Sponsor or person
Institute
Department of Pediatrics, Kansai medical university
Institute
Department
Personal name
Funding Source
Organization
Department of Pediatrics, Kansai medical university
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
関西医科大学附属滝井病院
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 12 | 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
Preinitiation
Date of protocol fixation
| 2014 | Year | 12 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 12 | 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
| 2014 | Year | 11 | Month | 29 | Day |
Last modified on
| 2014 | Year | 11 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000018368
