UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000032836 |
|---|---|
| Receipt number | R000037444 |
| Scientific Title | Evaluation of performance in NVF-21P |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2018/06/01 16:04:19 |
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Basic information
Public title
Evaluation of performance in NVF-21P
Acronym
Evaluation of performance in NVF-21P
Scientific Title
Evaluation of performance in NVF-21P
Scientific Title:Acronym
Evaluation of performance in NVF-21P
Region
| Japan |
Condition
Condition
Chronic Renal Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Usefulness and safety of NVF series, which is expected to improve diffusion by narrowing inner diameter of hollow fiber, are verified when this device is used under HDF therapy with high substitution volume.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of unidentified complaint
Key secondary outcomes
Evaluation of performance such as removal for substances and albumin loss and biocompatibility.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Two kinds of hemodiafilter are used for 2 month each.
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Stable maintenance dialysis patient without urine
A patient treated with TDF-PV
Key exclusion criteria
A patient who was judged to be unsuitable for this study by doctors
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Izumi Seino |
Organization
Tendo Onsen Yabuki Clinic
Division name
Clinical Engineering Department
Zip code
Address
2-10 Ichi-chome, Kuwanomachi, Tendo-shi, Yamagata
TEL
023-656-9811
izu3116@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Izumi Seino |
Organization
Tendo Onsen Yabuki Clinic
Division name
Clinical Engineering Department
Zip code
Address
2-10 Ichi-chome, Kuwanomachi, Tendo-shi, Yamagata
TEL
023-656-9811
Homepage URL
izu3116@gmail.com
Sponsor or person
Institute
Tendo Onsen Yabuki Clinic
Institute
Department
Personal name
Funding Source
Organization
Toray Industries Inc.
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
| 2018 | Year | 06 | Month | 30 | 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
| 2016 | Year | 11 | Month | 25 | Day |
Date of IRB
Anticipated trial start date
| 2017 | Year | 02 | Month | 21 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 01 | Day |
Last modified on
| 2018 | Year | 06 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037444
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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