UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017273 |
|---|---|
| Receipt number | R000020039 |
| Scientific Title | Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects |
| Date of disclosure of the study information | 2015/04/30 |
| Last modified on | 2016/06/27 10:14:53 |
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Basic information
Public title
Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects
Acronym
VASCPREDICT_Study
Scientific Title
Verifying correlation between atherosclerosis predictor and plasma refilling rate in hemodialysis sub jects
Scientific Title:Acronym
VASCPREDICT_Study
Region
| Japan |
Condition
Condition
Chronic maintenance hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Malignancy
Genomic information
NO
Objectives
Narrative objectives1
It is examined whether there are the correlations between plasma sCD40L concentration before and after dialysis and PRR.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Correlation between concentration of plasma sCD40L and PRR during dialysis.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Device,equipment |
Interventions/Control_1
Hemodialysis therapy with polysulfone type dialyzer.
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
1)A patient who are continuously treated with three 4-h dialysis sessions per week using polysulfone type dialyzer.
2)A patient whose age is more than 20 years old when he/she is enrolled.
3)A patient whose dialysis vintage is more then 1 year when he is enrolled.
4)A patient that vascular access is an arter iovenous fistula.
Key exclusion criteria
1)A patient who has been treated with the renal replacement therapies other than hemodialysis 1 year before.
2)A patient who has the comorbidities including malignant tumor,liver disease,hematologic disease and gastrointestinal hemorrhage when he/she is enrolled.
3))A patient who is pregnant or intends to be pregnant within the period of study.
4))A patient who is judged inadequate by participating physicians.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shoichi Uemura |
Organization
Bousei Kannai Clinic
Division name
Bousei Kannai Clinic
Zip code
Address
9F Yokohama Oodori Kouen Bldg.2-4-1 Hourai-cho, Naka-ku,Yokohama city,Kanagawa
TEL
045-243-5711
showak04@eagle.ocn.ne.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shoichi Uemura |
Organization
Bousei Kannai Clinic
Division name
Bousei Kannai Clinic
Zip code
Address
9F Yokohama Oodori Kouen Bldg.2-4-1 Hourai-cho, Naka-ku,Yokohama city,Kanagawa
TEL
045-243-5711
Homepage URL
showak04@eagle.ocn.ne.jp
Sponsor or person
Institute
Bousei Kannai Clinic
Institute
Department
Personal name
Funding Source
Organization
TORAY INDUXTRIES Inc.
Organization
Division
Category of Funding Organization
Profit organization
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
松和会 望星関内クリニック
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 04 | Month | 30 | 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
| 2015 | Year | 02 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 04 | Month | 30 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2015 | Year | 04 | Month | 25 | Day |
Last modified on
| 2016 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020039
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
