UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020526 |
|---|---|
| Receipt number | R000023695 |
| Scientific Title | Effect of Vitamin E-coated Dialyzer on the Ratio of Oxidized and Reduced Form of Serum Albumin |
| Date of disclosure of the study information | 2016/01/11 |
| Last modified on | 2018/01/13 00:27:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Effect of Vitamin E-coated Dialyzer on the Ratio of Oxidized and Reduced Form of Serum Albumin
Acronym
Vitamin E-coated Dialyzer and Oxidative Stress
Scientific Title
Effect of Vitamin E-coated Dialyzer on the Ratio of Oxidized and Reduced Form of Serum Albumin
Scientific Title:Acronym
Vitamin E-coated Dialyzer and Oxidative Stress
Region
| Japan |
Condition
Condition
endstage kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The incidence of cardiovascular disease is known to be high in patients receiving hemodialysis therapy. According to the annual survey conducted by the Japanese Society of Hemodialysis Therapy, more than 30% of hemodialysis patients die of heart failure, myocardial infarction and cardiac sudden death. Many of the traditional and nontraditional cardiovascular risk factors that could affect cardiovascular disorder can be found in association with endstage kidney disease. Among these, oxidative stress is considered to predispose individuals to the development of cardiovascular disease in these patients.
The amount of human mercaptoalbumin (reduced form; HMA) and human nonmercaptoalbumin (oxidized form; HNA), and their ratio are considered to reflect oxidative stress status. HMA/HNA ratio is 75:25 in normal subjects. HNA has been reported to increases in patients with chronic renal insufficiency. We found that HMA/HNA ratio decreased to 55:45 in hemodialysis patients and the ratio increased after a single dialysis session. Therefore, it is important to optimize dialysis therapy using HMA/HNA ratio as a marker of oxidative stress.
VPS-HA membrane is vitamin E-coated dialysis membrane which has been known to have antioxidant effect. The aim of the present study is to evaluate the effect of vitamin E-coated dialyzer on the HMA/HNA ratio in hemodialysis patients and assess the antioxidant effect of this membrane.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change in the ratio of oxidized and reduced form of serum albumin after 6 months hemodialysis therapy using vitamin E-coated dialyzer
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
vitamin E-coated polysulfon membrane
three times a week, 4 hours per session, 6 months
Interventions/Control_2
regular polysulfon membrane
three times a week, 4 hours per session, 6 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
| 30 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. Receiving dialysis therapy for more tha 1 year.
2. Receiving dialysis therapy using polysulfone membrane.
3. written informed consent is obtained.
Key exclusion criteria
1. Patients who have malignancy.
2. Patients who have severe liver disease.
3. Patients who are unqualified to the study.
Target sample size
15
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takahashi |
Organization
Kansai Medical University Kori Hospital
Division name
Dialysis Center
Zip code
Address
8-45 Kori Hondori-cho, Neyagawa, Osaka
TEL
072-832-5321
takahasn@kouri.kmu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nobuyuki Takahashi |
Organization
Kansai Medical University Kori Hospital
Division name
Dialysis Center
Zip code
Address
8-45 Kori Hondori-cho, Neyagawa, Osaka
TEL
072-832-5321
Homepage URL
takahasn@kouri.kmu.ac.jp
Sponsor or person
Institute
Kansai Medical University Kori Hospital
Institute
Department
Personal name
Funding Source
Organization
Asahikasei Medical Co.
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Fujita Health University
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
関西医科大学香里病院
Other administrative information
Date of disclosure of the study information
| 2016 | Year | 01 | Month | 11 | 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
| 2015 | Year | 11 | Month | 30 | Day |
Date of IRB
Anticipated trial start date
| 2016 | Year | 03 | Month | 31 | Day |
Last follow-up date
| 2017 | Year | 06 | Month | 30 | Day |
Date of closure to data entry
| 2017 | Year | 09 | Month | 30 | Day |
Date trial data considered complete
| 2017 | Year | 09 | Month | 30 | Day |
Date analysis concluded
| 2017 | Year | 11 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2016 | Year | 01 | Month | 11 | Day |
Last modified on
| 2018 | Year | 01 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023695
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
