UMIN-CTR Clinical Trial

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
Email	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
Email	kk4794@naramed-u.ac.jp

Sponsor
Institute	Department of Anesthesiology, Nara Medical University
Institute
Department

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
Email	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
URL(English)	https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000055658