UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002039 |
|---|---|
| Receipt number | R000002454 |
| Scientific Title | The influence of dialyzer membrane on microcirculation and inflammation in hemodialysis patients. |
| Date of disclosure of the study information | 2009/06/03 |
| Last modified on | 2011/07/11 21:37:01 |
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Basic information
Public title
The influence of dialyzer membrane on microcirculation and inflammation in hemodialysis patients.
Acronym
The influence of dialyzer membrane on microcirculation and inflammation.
Scientific Title
The influence of dialyzer membrane on microcirculation and inflammation in hemodialysis patients.
Scientific Title:Acronym
The influence of dialyzer membrane on microcirculation and inflammation.
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate whether microcirculation, inflammation and nutirition in hemodialysis patients are influenced by two kinds of dialysis membrane.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
hs-CRP, IL-6, events of hypotension during hemodialysis, SPP and baPWV will be measured at 0, 3, 6, 9 and 12 months after study initiation.
Key secondary outcomes
serum creatinine, serum pre-albumin, serum albumin, muscle volume and BMI will be measured at 0, 3, 6, 9 and 12 months after study initiation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Patients of Group 1 will receive EVAL membrane for 12 months.
Interventions/Control_2
Patients of Group 2 will receive vitamin E-coated PS membrane for 12 months.
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
| 90 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Hemodialysis patients who used EVAL membrane more than 3 months prior to study initiation.
Key exclusion criteria
Patients who did not agree with participating this clinical study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hayato Nishida |
Organization
Yamagata University, Faculty of Medicine
Division name
Department of Urology
Zip code
Address
2-2-2 iidanishi, Yamagata-city, Yamagata, Japan.
TEL
023-633-1122
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hayato Nishida |
Organization
Yamagata University, Faculty of Medicine
Division name
Department of Urology
Zip code
Address
TEL
Homepage URL
hnishida331@yahoo.co.jp
Sponsor or person
Institute
Yabuki Hospital
Institute
Department
Personal name
Funding Source
Organization
ASAHI KASEI KURARAY MEDICAL CO., LTD.
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
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 06 | Month | 03 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Nine patients were excluded from the study because they were out of the protocol.
IL-6 was significantly increased in VPS group, however no other parameters changed significantly during follow-up periods. No significant differences between VPS group and EK group were observed during study periods.
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
| 2009 | Year | 02 | Month | 08 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 03 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
| 2010 | Year | 03 | Month | 01 | Day |
Date trial data considered complete
| 2010 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2010 | Year | 11 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 06 | Month | 03 | Day |
Last modified on
| 2011 | Year | 07 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002454
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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