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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001429
Receipt No. R000001737
Scientific Title Impact of ultrapure dialysate on white blood cells activation in hemodialysis patients
Date of disclosure of the study information 2008/10/15
Last modified on 2010/01/24

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Basic information
Public title Impact of ultrapure dialysate on white blood cells activation in hemodialysis patients
Acronym Ultrapure dialysate and white blood cells activation
Scientific Title Impact of ultrapure dialysate on white blood cells activation in hemodialysis patients
Scientific Title:Acronym Ultrapure dialysate and white blood cells activation
Region
Japan

Condition
Condition hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 During a HD session, bioincompatibility, in which adverse effects are induced in the blood after contact with components of the HD system, is important. Consequently, the purity of the dialysate and the permeability of the membrane to dialysate contaminants might contribute in part to the acute and long-term complications that afflict HD patients. Conventional dialysate (CD) has been shown to contain microbial components. Increasing dialysate purity effectively reduces chronic inflammation and oxidative stress. However, it remains unclear how dialysate purity affect white blood cells (WBC) activation. In the present study, impact of purified dialysate on activation of WBC (neutrophils and monocytes) will be analyzed.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes Comparison of expression levels of white blood cells (neutrophils and monocytes) surface receptors (TR2, TR4, CD11b, CD14, CD16, CD18), inflammatory factors (cytokone, myeloperoxidase) releasing from those cells between CD and ultrapuredialysate.
Key secondary outcomes Comparison of serum protein, nutritional state

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Dose comparison
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Prevention
Type of intervention
Device,equipment
Interventions/Control_1 ultrapure dialysate
Interventions/Control_2 conventional dialysate
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) Renal dysfunction: end-stage chronic kidney disease, require maintenance dialysis due to renal dysfunction
2) Expected survival time is more than 6 months
3) Aged 20 years over
4) Fully informed consent was obtained
Key exclusion criteria 1) Malignancy
2) Malnutrition
3) Active inflammatory or infectious disease
4)) Abdominal ascites or pleural effusion
5) Pregnancy
6) Judged inappropriate for this study by the physicians
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Hirokazu Honda
Organization Showa University School of Medicine
Division name Division of Nephrology , Depertment of Medicine
Zip code
Address 1-5-8, Hatanodai, Shinagawa-ku,142-8666, Tokyo
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Showa University School of Medicine
Division name Division of Nephrology, Department of Medicine
Zip code
Address
TEL
Homepage URL
Email hondah@med.showa-u.ac.jp

Sponsor
Institute Division of Nephrology Department of Medicine Showa University School of Medicine
Institute
Department

Funding Source
Organization Division of Nephrology Department of Medicine Showa University School of Medicine
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
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
2008 Year 10 Month 15 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
2008 Year 07 Month 01 Day
Date of IRB
Anticipated trial start date
2008 Year 07 Month 01 Day
Last follow-up date
2009 Year 07 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2008 Year 10 Month 14 Day
Last modified on
2010 Year 01 Month 24 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001737

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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