UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040267 |
|---|---|
| Receipt number | R000045862 |
| Scientific Title | Biocompatibility evaluation of various blood purification therapies |
| Date of disclosure of the study information | 2020/05/01 |
| Last modified on | 2020/04/29 12:21:41 |
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Basic information
Public title
Biocompatibility evaluation of various blood purification therapies
Acronym
Biocompatibility evaluation of various blood purification therapies
Scientific Title
Biocompatibility evaluation of various blood purification therapies
Scientific Title:Acronym
Biocompatibility evaluation of various blood purification therapies
Region
| Japan |
Condition
Condition
Patients with end-stage renal failure undergoing hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A comparative study of biocompatibility between pre-dilution online HDF and post-dilution online HDF with constant filtration performance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
White blood cell count, platelet count, high-sensitivity CRP, plateletderived micro particles change rate and PTX3, IL-6 production rate before and after treatment
Key secondary outcomes
Albumin leakage, transmembrane pressure difference
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Perform pre-dilution online HDF and post-dilution online HDF using MFX-25Ueco (Nipro Corporation) for 2 weeks. HD with PES-25Da eco (Nipro Corporation) is performed for 2 weeks before and after each treatment.
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
| 20 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Regardless of gender, hospitalization / outpatient status, medical history, or presence of complications
Key exclusion criteria
Patients with C-reactive protein (CRP); 0.3 mg / dL or more by prior blood test
Target sample size
16
Research contact person
Name of lead principal investigator
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Michiwaki |
Organization
Kawashima hospital
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho,Tokushima city 770-0011,Tokushima,Japan
TEL
088-631-0110
michiwaki@khg.or.jp
Public contact
Name of contact person
| 1st name | Hiroyuki |
| Middle name | |
| Last name | Michiwaki |
Organization
Kawashima hospital
Division name
Department of Clinical Engineering
Zip code
770-0011
Address
1-39 Kitasakoichiban-cho,Tokushima city 770-0011,Tokushima,Japan
TEL
088-631-0110
Homepage URL
michiwaki@khg.or.jp
Sponsor or person
Institute
Kawashima hospital
Institute
Department
Personal name
Funding Source
Organization
Nipro Corporation
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
Kawashima hospital
Address
1-39 Kitasakoichiban-cho,Tokushima city 770-0011,Tokushima,Japan
Tel
088-631-0110
michiwaki@khg.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
| 2020 | 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
16
Results
Results date posted
Results Delayed
| Delay expected |
Results Delay Reason
In the middle of posting
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 | 12 | Month | 28 | Day |
Date of IRB
| 2016 | Year | 02 | Month | 02 | Day |
Anticipated trial start date
| 2016 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2020 | Year | 04 | Month | 29 | Day |
Last modified on
| 2020 | Year | 04 | Month | 29 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045862
| 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 |
