UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015454 |
|---|---|
| Receipt number | R000017970 |
| Scientific Title | Pentraxin3 as a new biomarker of peritoneal injury and cardiovascular event in peritoneal daialysis patients. |
| Date of disclosure of the study information | 2014/10/17 |
| Last modified on | 2014/10/17 11:21:19 |
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Basic information
Public title
Pentraxin3 as a new biomarker of peritoneal injury and cardiovascular event in peritoneal daialysis patients.
Acronym
PTx3 as a new marker of periotneal injury and CV event in PD patients
Scientific Title
Pentraxin3 as a new biomarker of peritoneal injury and cardiovascular event in peritoneal daialysis patients.
Scientific Title:Acronym
PTx3 as a new marker of periotneal injury and CV event in PD patients
Region
| Japan |
Condition
Condition
peritoneal dailysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of PTx3 as anew marker of peritoneal injury and cardiovascular event
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
peritonael injury and cardiovascular event
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
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
peritoneal dialysis patients(initiation and maintaied)
Key exclusion criteria
peritonitis within 6 manths
severe cardiovascular disease
sepsis
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | HiroakiIo |
Organization
Division of Nephrology, Department of internal medicine, Faculty of Juntendo University
Division name
Nephrology
Zip code
Address
2-1-1 Hongo Bunkyou-ku Tokyo, Japan
TEL
81-3-3813-3111
hiroaki@juntneod.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | HiroakiIo |
Organization
Division of Nephrology, Department of internal medicine, Faculty of Juntendo University
Division name
Nephrology
Zip code
Address
2-1-1 Hongo Bunkyou-ku Tokyo, Japan
TEL
81-3-3813-3111
Homepage URL
hiroaki@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
Institute
Department
Personal name
Funding Source
Organization
none
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
| 2014 | Year | 10 | Month | 17 | 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
Enrolling by invitation
Date of protocol fixation
| 2014 | Year | 10 | Month | 03 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2020 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
before start
Management information
Registered date
| 2014 | Year | 10 | Month | 17 | Day |
Last modified on
| 2014 | Year | 10 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017970
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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