UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017812 |
|---|---|
| Receipt number | R000020636 |
| Scientific Title | Evaluation Study of Nutrition Status in the hemodialysis patients with the vitamin E-bonded dialyzer. |
| Date of disclosure of the study information | 2015/06/06 |
| Last modified on | 2025/12/11 14:28:03 |
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Basic information
Public title
Evaluation Study of Nutrition Status in the hemodialysis patients with the vitamin E-bonded dialyzer.
Acronym
Evaluation Study of Nutrition Status in the hemodialysis patients with the vitamin E-bonded dialyzer.
Scientific Title
Evaluation Study of Nutrition Status in the hemodialysis patients with the vitamin E-bonded dialyzer.
Scientific Title:Acronym
Evaluation Study of Nutrition Status in the hemodialysis patients with the vitamin E-bonded dialyzer.
Region
| Japan |
Condition
Condition
CKD/ESRD
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Hemodialysis patients are at risk of protein-energy malnutrition (PEM).
Oxidative stress and chronic inflammation are the cause of the PEM. The vitamin E-bonded dialyzer (VEM) has anti-inflammatory and anti-nociceptive effects. The aim of this study is to investigate the utility of the VEM for The PEM of hemodialysis patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
transthyretin
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
vitamin E-bonded polysulfone membrane dialyzer
Interventions/Control_2
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
| 65 | years-old | <= |
Age-upper limit
| 90 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Adult human undergoing chronic dialysis therapy.
And the mean of their serum albumin for the three months before this study is less than 3.8g/dl.
Key exclusion criteria
AST or ALT for the three months before this study is more than 20 IU/L.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nozomu Yamanaka |
Organization
National Defense Medical College
Division name
Department of Surgery2
Zip code
Address
Namiki 3-2, Tokorozawa, Saitama 359-8513, Japan
TEL
04-2995-1650
non0101@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Nozomu Yamanaka |
Organization
National Defense Medical College
Division name
Department of Surgery2
Zip code
Address
Namiki 3-2, Tokorozawa, Saitama 359-8513, Japan
TEL
04-2995-1650
Homepage URL
non0101@hotmail.com
Sponsor or person
Institute
National Defense Medical College
Institute
Department
Personal name
Funding Source
Organization
Vitamembrane study group
Organization
Division
Category of Funding Organization
Other
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
イムス富士見総合病院（埼玉県）
イムス三芳総合病院（埼玉県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 06 | 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
Terminated
Date of protocol fixation
| 2014 | Year | 12 | Month | 19 | Day |
Date of IRB
| 2015 | Year | 03 | Month | 20 | Day |
Anticipated trial start date
| 2015 | Year | 06 | Month | 08 | Day |
Last follow-up date
| 2017 | Year | 05 | Month | 09 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2025 | Year | 12 | Month | 11 | Day |
Other
Other related information
Management information
Registered date
| 2015 | Year | 06 | Month | 04 | Day |
Last modified on
| 2025 | Year | 12 | Month | 11 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020636
