UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000000620 |
|---|---|
| Receipt number | R000000752 |
| Scientific Title | Okayama Screening Study for Anderson-Fabry Disease in Maintenance Dialysis |
| Date of disclosure of the study information | 2007/02/28 |
| Last modified on | 2014/02/28 09:15:28 |
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Basic information
Public title
Okayama Screening Study for Anderson-Fabry Disease in Maintenance Dialysis
Acronym
O-SAFETY
Scientific Title
Okayama Screening Study for Anderson-Fabry Disease in Maintenance Dialysis
Scientific Title:Acronym
O-SAFETY
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the incidence of Fabry disease in patients undergoing maintenance dialysis in Okayama University and affiliated hospitals by screening for alpha-galactosidase A deficiency
Basic objectives2
Others
Basic objectives -Others
epidemiologic study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
plasma alpha-galactosidase A activity
Key secondary outcomes
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
| 5 | years-old | <= |
Age-upper limit
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients with maintenance dialysis (hemo- and peritoneal dialysis)
Key exclusion criteria
None
Target sample size
500
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirofumi Makino |
Organization
Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikata-cho, Okayama 700-8558, Japan
TEL
086-235-7235
hitoshis@md.okayama-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hitoshi Sugiyama |
Organization
Okayama University Graduate School, Okayama, Japan
Division name
Department of Medicine and Clinical Science
Zip code
Address
2-5-1 Shikatacho Kitaku, Okayama, Japan
TEL
086-235-7235
Homepage URL
hitoshis@md.okayama-u.ac.jp
Sponsor or person
Institute
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
Institute
Department
Personal name
Funding Source
Organization
Department of Medicine and Clinical Science, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan
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
Other administrative information
Date of disclosure of the study information
| 2007 | Year | 02 | Month | 28 | 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
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
| 2006 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2007 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2011 | Year | 08 | Month | 01 | Day |
Date analysis concluded
| 2011 | Year | 08 | Month | 01 | Day |
Other
Other related information
Prospective study
Management information
Registered date
| 2007 | Year | 02 | Month | 28 | Day |
Last modified on
| 2014 | Year | 02 | Month | 28 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000752
