UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009786 |
|---|---|
| Receipt number | R000011459 |
| Scientific Title | Japan Fabry Disease Registry and Cohort Study |
| Date of disclosure of the study information | 2013/01/15 |
| Last modified on | 2018/06/19 15:49:11 |
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Basic information
Public title
Japan Fabry Disease Registry and Cohort Study
Acronym
J-FDR-CS
Scientific Title
Japan Fabry Disease Registry and Cohort Study
Scientific Title:Acronym
J-FDR-CS
Region
| Japan |
Condition
Condition
Fabry disease
Classification by specialty
| Medicine in general | Nephrology | Pediatrics |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of enzyme replacement therapy on renal prognosis and patient survival in Japanese patients with Fabry disease
Basic objectives2
Others
Basic objectives -Others
To establish the clinical parameters affecting therapy and prognosis in patients with Fabry disease
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
renal prognosis, end-stage renal disese, death (CVD, total)
Key secondary outcomes
proteinuria, enzyme replacement therapy
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with Fabry disease (newly-identified or already-diagnosed)
Key exclusion criteria
not particular
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ichiei Narita |
Organization
Niigata University Graduate School of Medical and Dental Sciences
Division name
Biological Functions and Medical Control, Homeostatic Regulation and Development
Zip code
Address
754, Ichibancho, Asahimachidori, Chuo-ku, Niigata-shi, NIIGATA, 951-8510,
TEL
03-3814-4455
fab@n-place.co.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroshi Morinaga |
Organization
Japan Fabry Nephropathy Study Group
Division name
Working Group for cohort study
Zip code
Address
2-5-1 Shikata-cho, Kita-ku, Okayama, Japan
TEL
086-223-7151
Homepage URL
fab@n-place.co.jp
Sponsor or person
Institute
Japan Fabry Nephropathy Study Group
Institute
Department
Personal name
Funding Source
Organization
The Kidney Foundation, Japan
Organization
Division
Category of Funding Organization
Non profit foundation
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
| 2013 | Year | 01 | Month | 15 | 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
| 2012 | Year | 11 | Month | 24 | Day |
Date of IRB
Anticipated trial start date
| 2013 | Year | 01 | Month | 15 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
The data on patients with Fabry disease were recorded at each institution and registered on the web page of the J-FDR-CS utilizing the UMIN-INDICE system. Multicenter prospective observational study will be performed in annual survey for five years.
Management information
Registered date
| 2013 | Year | 01 | Month | 15 | Day |
Last modified on
| 2018 | Year | 06 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000011459
