UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001275 |
|---|---|
| Receipt number | R000001552 |
| Scientific Title | Clinical efficacy of high-flux polysulfone dialyzer, FX-S |
| Date of disclosure of the study information | 2008/07/29 |
| Last modified on | 2014/09/29 14:36:48 |
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Basic information
Public title
Clinical efficacy of high-flux polysulfone dialyzer, FX-S
Acronym
Clinical efficacy of FX-S
Scientific Title
Clinical efficacy of high-flux polysulfone dialyzer, FX-S
Scientific Title:Acronym
Clinical efficacy of FX-S
Region
| Japan |
Condition
Condition
hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
High prevalent of CVD and HD-related complications in HD patients are closely associated with clinical outcome and morbidity. Sufficient removal of uremic toxin per se by dialysis using biocompatible dialyzer is important in those patients. Recently a new class of dialyzer with increased performance and outstanding biocompatibility was developed. The purpose of the present study is to estimate function and efficacy of new dialyzer compared with the classical routinely used high-flux polysulfone
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
At baseline, 3 months and 6 months, parameters of lipid, inflammation and oxidative stress
Key secondary outcomes
effectiveness for anemia and nutrition
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Blinding
Open -but assessor(s) are 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
Type 5 high-flux polysulfone (PS) dialyzer (FX-S)
Interventions/Control_2
Type 4 PS dialyzer (FX)
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
All recruited patients underwent routine conventional bicarbonate HD three times a week (3 - 4 hours per session) using standard high-flux polysulfone (PS), and fully informed consent was obtained.
Key exclusion criteria
Patients with clinical signs of overt infection, acute vasculitis, or liver disease at the time of recruitment were excluded. So that lipid metabolism could be evaluated, patients taking lipid-lowering drugs such as statins, fibrates, ezetimibe, or ethyl icosapentate were also excluded from the study
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Tadao Akizawa |
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 Internal Medicine
Zip code
Address
TEL
Homepage URL
hondah@med.showa-u.ac.jp
Sponsor or person
Institute
Division of Nephrology Department of Internal Medicine Showa University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Division of Nephrology Department of Internal 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 | 07 | Month | 29 | 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 | 05 | Month | 10 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2009 | Year | 12 | 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 | 07 | Month | 29 | Day |
Last modified on
| 2014 | Year | 09 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001552
