UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000016854 |
|---|---|
| Receipt number | R000019564 |
| Scientific Title | Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers |
| Date of disclosure of the study information | 2015/03/20 |
| Last modified on | 2018/02/22 17:24:35 |
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Basic information
Public title
Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers
Acronym
Validation study of lyso-Gb3 plasma concentration in healthy Japanese volunteers
Scientific Title
Validation study for lyso-Gb3 plasma concentration in healthy adult or child Japanese volunteers
Scientific Title:Acronym
Validation study of lyso-Gb3 plasma concentration in healthy Japanese volunteers
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Medicine in general | Gastroenterology | Cardiology |
| Endocrinology and Metabolism | Nephrology | Neurology |
| Ophthalmology | Dermatology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To investigate the reference range of plasma Lyso-Gb3 in healthy adult or child Japanese volunteers
Basic objectives2
Others
Basic objectives -Others
To investigate the reference range of plasma Lyso-Gb3 for the diagnosis of Fabry disease
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Lyso-Gb3 concentration in plasma
Key secondary outcomes
GLA activity in plasma
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 15 | years-old | <= |
Age-upper limit
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
*Subjects who fulfill the following 1)-3) criteria
1) Japanese men or women aged 15 through 70 year at informed consent
2) Volunteers who are fully informed of and understand the objectives, procedures, and possible risks of the study and provide the written voluntary consent to participate in the study. For volunteers younger than 20 years at informed consent, Consent should be obtained from the volunteers' legal acceptable representatives in addition to the consent from the volunteers.
3) Volunteers who can claim their symptoms
Key exclusion criteria
1)Volunteers who were diagnosed or suspected as Fabry disease
2)Volunteers with a history of receiving GLA enzyme replacement therapy (Replagal® or Fabrazyme®)
3)Volunteers who have previous or current disease or symptoms shown in Table 3
4)Volunteers who any their relatives (parents, brothers, sisters, sons, daughters, grandparents, or cousins) have Fabry disease
5)Volunteers who received amiodarone, chloroquine or hydroxychloroquine within 6 months before informed consent or plan to receive either of the drugs during the study
6)Volunteers who are considered unhealthy (having clinical issues for which any treatments or clinical observation are necessary) by the investigator at screening
7)Volunteers who have any histories of cardiovascular, liver, kidney, lung, endocrine, digestive, blood, respiratory, neuropsychiatric, or central nervous system diseases and are considered ineligible for the study by the investigator.
8)Volunteers who are otherwise considered ineligible for the study by the investigator
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sakuraba |
Organization
Meiji Pharmaceutical University
Division name
Department of Clinical Genetics
Zip code
Address
2-522-1 Noshio,Kiyose City Tokyo 204-8588,Japan
TEL
042-495-8923
sakuraba@my-pharm.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tadayasu Togawa |
Organization
Meiji Pharmaceutical University
Division name
Department of Functional Bioanalysis
Zip code
Address
2-522-1 Noshio,Kiyose City Tokyo 204-8588,Japan
TEL
042-495-8992
Homepage URL
tadayasu@my-pharm.ac.jp
Sponsor or person
Institute
Meiji Pharmaceutical University
Institute
Department
Personal name
Funding Source
Organization
Sumitomo Dainippon Pharma Co., Ltd.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
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
シーピーシー治験病院（鹿児島県）/ CPC Clinical Trial Hospital (KAGOSHIMA)
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 03 | Month | 20 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Clin Exp Nephrol. doi: 10.1007/s10157-017-1525-3.(open access)
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
| 2015 | Year | 03 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 03 | Month | 25 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Prospective observational study
Management information
Registered date
| 2015 | Year | 03 | Month | 20 | Day |
Last modified on
| 2018 | Year | 02 | Month | 22 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000019564
