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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002039
Receipt No. 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

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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
Email

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
Email hnishida331@yahoo.co.jp

Sponsor
Institute Yabuki Hospital
Institute
Department

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
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002454

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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