UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000047538 |
|---|---|
| Receipt number | R000054212 |
| Scientific Title | Randomized controlled trial of dialyzer used by dialysis initiation patients with discontinuation of production of EVAL membrane dialyzer |
| Date of disclosure of the study information | 2022/05/01 |
| Last modified on | 2022/04/20 16:27:06 |
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Basic information
Public title
Randomized controlled trial of dialyzer used by dialysis initiation patients with discontinuation of production of EVAL membrane dialyzer
Acronym
Initiating dialyzer trial
Scientific Title
Randomized controlled trial of dialyzer used by dialysis initiation patients with discontinuation of production of EVAL membrane dialyzer
Scientific Title:Acronym
Initiating dialyzer trial
Region
| Japan |
Condition
Condition
Chronic Renal Failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The production of the EVAL membrane dialyzer, which has been used as a initiating dialyzer in our hospital, has been discontinued, so we will compare dialyzer with different types of materials, and verify the optimal dialyzer while observing the remaining renal function and nutritional status.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Indefinite complaint and nutritional status 0, 2, 6, 12 months after dialysis initiation.
Key secondary outcomes
3 years survival rate after dialysis initiation.
Residual renal function 0, 2, 6, 12 months after dialysis initiation.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
4
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Treatment with one dialyzer chosen from NF-U.
Interventions/Control_2
Treatment with one dialyzer chosen from.FDX
Interventions/Control_3
Treatment with one dialyzer chosen from .PES-Galpha.
Interventions/Control_4
Treatment with one dialyzer chosen from.VPS-HA.
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
Hemodialysis initiation patients
Patients >= 20 years and <85 years of age at the time of informed consent.
Key exclusion criteria
Medical history of the peritoneal dialysis.
Difficulties for self-management.
Patients who are going to be transferred to another hospital.
Patients in the opinion of the principal investigator to disqualify from participation.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Ikuto |
| Middle name | |
| Last name | Masakane |
Organization
Medical corporation Seieikai
Yabuki hospital
Division name
Renal failure measures room manager
Zip code
9900980
Address
5-5,shimaKita-4tyoume,Yamagata
TEL
023-682-8566
imasakan.aipod@seieig.or.jp
Public contact
Name of contact person
| 1st name | Norio |
| Middle name | |
| Last name | Suzuki |
Organization
Medical corporation Seieikai
Division name
Department of clinical engineering
Zip code
9900043
Address
6-17,honntyou1tyome,Yamagata
TEL
023-615-1877
Homepage URL
suzukin@seieig.or.jp
Sponsor or person
Institute
Medical corporation Seieikai
Yabuki hospital
Institute
Department
Personal name
Funding Source
Organization
Medical corporation Seieikai
Yabuki hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical corporation Seieikai
Honmachi Yabuki clinic
Tendou Onsen Yabuki clinic
Nanyou Yabuki clinic
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Medical corporation Seieikai Yabuki hospitalEthics Review Board
Address
5-5,shimaKita-4tyoume,Yamagata
Tel
023-682-8566
imasakan.aipod@seieig.or.jp
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
| 2022 | Year | 05 | Month | 01 | 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
60
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
No longer recruiting
Date of protocol fixation
| 2019 | Year | 05 | Month | 01 | Day |
Date of IRB
| 2019 | Year | 05 | Month | 01 | Day |
Anticipated trial start date
| 2019 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2024 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Enrollment in this clinical study is planned that the initiation dialysis patients who meet our criteria for selection are sequentially chosen. Hemodialysis is performed using four dialyzers(NF-U,FDX,PES-Galfa,VPS-HA).The surface area of dialyzer is chosen size suitable for each research participants. Research participants are randomized by assigned to one of dialyzers sequentially.
Management information
Registered date
| 2022 | Year | 04 | Month | 20 | Day |
Last modified on
| 2022 | Year | 04 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000054212
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
