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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000029038
Receipt No. R000033214
Scientific Title Investigation of complement activity between generic drug and barand-name drug for the use of anticoagulant during blood apheresis therapy
Date of disclosure of the study information 2017/09/07
Last modified on 2019/09/09

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Basic information
Public title Investigation of complement activity between generic drug and barand-name drug for the use of anticoagulant during blood apheresis therapy
Acronym The effect of anticoagulant for complement activity during hemodiafiltration therapy
Scientific Title Investigation of complement activity between generic drug and barand-name drug for the use of anticoagulant during blood apheresis therapy
Scientific Title:Acronym The effect of anticoagulant for complement activity during hemodiafiltration therapy
Region
Japan

Condition
Condition Sepsis
Classification by specialty
Cardiology Intensive care medicine
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Investigate of the difference between brand name mesylate nafamostat and its generic drug for the effect of complement activity during continuous hemodiafiltration
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes The difference of the complement activity with the use of brand name drug or generic drug
Key secondary outcomes The difference of the coagulation activity
or cytokine concentration with the use of brand name drug or generic drug

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Generic drug will use for the anticoagulant for the patients with receiving continuous hemodiafiltration therapy.
Interventions/Control_2 Brand name drug will use for the anticoagulant for the patients with receiving continuous hemodiafiltration therapy.
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 patients receiving blood purification thrapy
Key exclusion criteria age under 20 y.o.
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kazunori Fujino
Organization Shiga University of Medical Science
Division name Critical and Intensive care medicine
Zip code
Address Setatsukinowa-cho, Otsu city, Shiga prefecture
TEL 077-548-2929
Email kfujino@belle.shiga-med.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kazunori Fujino
Organization Shiga University of Medical Science
Division name Critical and Intensive care medicine
Zip code
Address Setatsukinowa-cho, Otsu city, Shiga prefecture
TEL 077-548-2929
Homepage URL
Email kfujino@belle.shiga-med.ac.jp

Sponsor
Institute Shiga University of Medical Science
Institute
Department

Funding Source
Organization Shiga University of Medical Science
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

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 09 Month 07 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 Terminated
Date of protocol fixation
2017 Year 02 Month 17 Day
Date of IRB
2014 Year 12 Month 12 Day
Anticipated trial start date
2017 Year 09 Month 08 Day
Last follow-up date
2018 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
2018 Year 03 Month 31 Day

Other
Other related information

Management information
Registered date
2017 Year 09 Month 07 Day
Last modified on
2019 Year 09 Month 09 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033214

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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