UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001429 |
|---|---|
| Receipt number | 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 12:45:23 |
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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
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
hondah@med.showa-u.ac.jp
Sponsor or person
Institute
Division of Nephrology Department of Medicine Showa University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001737
