UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000030628 |
|---|---|
| Receipt number | R000034954 |
| Scientific Title | Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U" |
| Date of disclosure of the study information | 2017/12/28 |
| Last modified on | 2018/10/03 09:37:59 |
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Basic information
Public title
Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U"
Acronym
"NF-U"trial
Scientific Title
Verification of the anti-malnutrition effect with albumin low-permeable PMMA dialyzer "NF-U"
Scientific Title:Acronym
"NF-U"trial
Region
| Japan |
Condition
Condition
End-stage renal disease requiring homodialysis
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
EVAL,NF-U and PS Performance comparison
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Using EVAL,NF,PS,compare albumin leakage.
Speculation
Albumin leakage :EVAL>NF-U=PS
Amino acid leakage :PS>NF-U=EVAL
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Dialyzers will be changed to the PMMA dialyzer'NF-U'.
Interventions/Control_2
EVAL dialyzer is continued and used
Interventions/Control_3
PS dialyzer is continued and used
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
The patients whose age is over 20 years at the time of enrollment in this study.
Key exclusion criteria
A patient who is judged as the inadequate subject of this study by the doctor.
Target sample size
18
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kzue Ueki |
Organization
Toho Hospital
Division name
Kidney dialysis senter
Zip code
Address
1155 Azami Ksakakemachi midorishi gunmaken
TEL
0277-76-6311
kueki@toho-hp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masaki Matsumura |
Organization
Toho Hospital
Division name
Kidney dialysis senter
Zip code
Address
1155 Azami Ksakakemachi midorishi gunmaken
TEL
0277-76-6311
Homepage URL
me6341mm@toho-hp.jp
Sponsor or person
Institute
Toho Hospital
Institute
Department
Personal name
Funding Source
Organization
Toray Medical
Organization
Division
Category of Funding Organization
Profit organization
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
| 2017 | Year | 12 | Month | 28 | 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
| 2017 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2018 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 04 | Month | 15 | Day |
Date trial data considered complete
| 2018 | Year | 04 | Month | 30 | Day |
Date analysis concluded
| 2018 | Year | 04 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2017 | Year | 12 | Month | 28 | Day |
Last modified on
| 2018 | Year | 10 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000034954
