UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014869 |
|---|---|
| Receipt number | R000017280 |
| Scientific Title | Observational study of atypical hemolytic uremic syndrome in Japan |
| Date of disclosure of the study information | 2014/09/01 |
| Last modified on | 2019/02/21 14:53:16 |
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Basic information
Public title
Observational study of atypical hemolytic uremic syndrome in Japan
Acronym
Observational study of atypical hemolytic uremic syndrome in Japan
Scientific Title
Observational study of atypical hemolytic uremic syndrome in Japan
Scientific Title:Acronym
Observational study of atypical hemolytic uremic syndrome in Japan
Region
| Japan |
Condition
Condition
Atypical hemolytic uremic syndrome (aHUS)
Classification by specialty
| Medicine in general | Hematology and clinical oncology | Nephrology |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To survey the epidemiological data of aHUS in Japan.
Basic objectives2
Others
Basic objectives -Others
Prospective and observational study
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
To recognize the morbidity, genetic abnormalities, prognosis, and outcomes of treatment in aHUS.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
aHUS patients
Key exclusion criteria
The patients who did not agree to this study.
Target sample size
300
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masaomi Nangaku |
Organization
The University of Tokyo Hospital School of Medicine
Division name
Division of Nephrology and Endocrinology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
03-3815-5411
mnangaku-tky@umin.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoichiro Ikeda |
Organization
The University of Tokyo Hospital School of Medicine
Division name
Division of Nephrology and Endocrinology
Zip code
Address
7-3-1 Hongo, Bunkyo-ku, Tokyo 113-8655 JAPAN
TEL
03-3815-5411
Homepage URL
ikeda-tky@umin.ac.jp
Sponsor or person
Institute
Working group of aHUS in Japan
Institute
Department
Personal name
Funding Source
Organization
National Institute of Public Health
Organization
Division
Category of Funding Organization
Japanese Governmental office
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
| 2014 | Year | 09 | 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
As of 2017, we have registered approximately 140 cases of aHUS.
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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 04 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 04 | 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
Establishing database system
Management information
Registered date
| 2014 | Year | 08 | Month | 15 | Day |
Last modified on
| 2019 | Year | 02 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017280
