UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000029038 |
|---|---|
| Receipt number | 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 09:11:31 |
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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
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
kfujino@belle.shiga-med.ac.jp
Sponsor or person
Institute
Shiga University of Medical Science
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000033214
