UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000048844 |
|---|---|
| Receipt number | R000055658 |
| Scientific Title | Evaluation of the pharmacokinetics of the nafamostat mesylate and changes in clotting factors for Continuous renal replacement therapy |
| Date of disclosure of the study information | 2022/09/03 |
| Last modified on | 2022/09/03 17:12:44 |
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Basic information
Public title
Changes in blood concentration of nafamostat mesilate during hemodialysis and changes in blood data related to blood coagulation
Acronym
Anticoagulants and clotting-related blood changes during hemodialysis
Scientific Title
Evaluation of the pharmacokinetics of the nafamostat mesylate and changes in clotting factors for Continuous renal replacement therapy
Scientific Title:Acronym
Evaluation of the pharmacokinetics of NM for CRRT
Region
| Japan |
Condition
Condition
sepsis, acute kidney injury
Classification by specialty
| Intensive care medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Observational study to examine drug metabolism and excretion in vivo
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Concentration of nafamostat mesylate in blood for Continuous renal replacement therapy
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with acute renal failure or chronic renal failure due to severe infection, sepsis, multiple organ failure, acute liver failure, acute pancreatitis, or acute circulatory failure who require CRRT and use nafamostat mesilate as an anticoagulant.
Key exclusion criteria
Patients who are pregnant or may be pregnant
Patients deemed inappropriate by the attending physician
Patients receiving blood products (concentrated red blood cells, fresh frozen plasma, platelets, etc.) during treatment
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | Masahiko |
| Middle name | |
| Last name | Kawaguchi |
Organization
Nara Medical University
Division name
Department of Anesthesiology
Zip code
634-8521
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-22-3051
drjkawa@naramed-u.ac.jp
Public contact
Name of contact person
| 1st name | Kouji |
| Middle name | |
| Last name | Konishi |
Organization
Nara Medical University Hospital
Division name
Medical Technology Center
Zip code
634-8521
Address
840 Shijo-Cho, Kashihara, Nara
TEL
0744-22-3051
Homepage URL
kk4794@naramed-u.ac.jp
Sponsor or person
Institute
Department of Anesthesiology, Nara Medical University
Institute
Department
Personal name
Funding Source
Organization
None
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
Nara Medical University Ethics Committee
Address
840 Shijo-Cho, Kashihara, Nara
Tel
0744-22-3051
ino_rinri@naramed-u.ac.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 | 09 | Month | 03 | 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
20
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
| 2014 | Year | 01 | Month | 08 | Day |
Date of IRB
| 2014 | Year | 02 | Month | 17 | Day |
Anticipated trial start date
| 2014 | Year | 10 | Month | 10 | Day |
Last follow-up date
| 2022 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2022 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2022 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2022 | Year | 12 | Month | 31 | Day |
Other
Other related information
Since drug metabolism is delayed in the state of liver dysfunction, drug persistence in the body is observed
Management information
Registered date
| 2022 | Year | 09 | Month | 03 | Day |
Last modified on
| 2022 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055658
| 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 |
