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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000040267
Receipt No. 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

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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
Email 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
Email michiwaki@khg.or.jp

Sponsor
Institute Kawashima hospital
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000045862

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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