UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037351 |
|---|---|
| Receipt number | R000042588 |
| Scientific Title | Validation Study on Prediction Model for Cardiovascular Events or All-cause Mortality in Incident Dialysis Patients |
| Date of disclosure of the study information | 2019/12/01 |
| Last modified on | 2019/07/12 17:32:21 |
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Basic information
Public title
Validation Study on Prediction Model for Cardiovascular Events or All-cause Mortality in Incident Dialysis Patients
Acronym
Prediction Model for Cardiovascular Events or All-cause Mortality in Incident Dialysis Patients
Scientific Title
Validation Study on Prediction Model for Cardiovascular Events or All-cause Mortality in Incident Dialysis Patients
Scientific Title:Acronym
Prediction Model for Cardiovascular Events or All-cause Mortality in Incident Dialysis Patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We will examine whether the prediction model we created before is validated in recent incident dialysis patients.
Basic objectives2
Others
Basic objectives -Others
Verification of the convenience of the prediction model
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Difference between predicted rate for composite outcomes including cardiovascular events or all-cause mortality and incidence rate
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
incident dialysis patients
Key exclusion criteria
Patients who died around the time of dialysis initiation or withdrew from maintenance dialysis
Target sample size
400
Research contact person
Name of lead principal investigator
| 1st name | Daijo |
| Middle name | |
| Last name | Inaguma |
Organization
Fujita Health University
Division name
Department of Nephrology
Zip code
470-1192
Address
Dengakugakubo 1-98, Kutsukake, Toyoake City, Aichi, Japan
TEL
0562-93-9245
daijo@fujita-hu.ac.jp
Public contact
Name of contact person
| 1st name | Daijo |
| Middle name | |
| Last name | Inaguma |
Organization
Fujita Health University
Division name
Department of Nephrology
Zip code
490-1192
Address
Dengakugakubo 1-98, Kutsukake, Toyoake City, Aichi, Japan
TEL
0562-93-9245
Homepage URL
daijo@fujita-hu.ac.jp
Sponsor or person
Institute
Fujita Health University
Institute
Department
Personal name
Funding Source
Organization
Fujita Health University
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Fujita Health University
Address
Dengakugakubo 1-98, Kutsukake, Toyoake City, Aichi, Japan
Tel
0562-93-9245
daijo@fujita-hu.ac.jp
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
| 2019 | 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
| 2019 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2019 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Nothing
Management information
Registered date
| 2019 | Year | 07 | Month | 12 | Day |
Last modified on
| 2019 | Year | 07 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000042588
