UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Dialyzability of faropenem sodium during hemodialysis in patients with chronic renal failure
Title of the study (Brief title)	Dialyzability of faropenem sodium during hemodialysis
Region	Japan

Condition
Condition	Chronic renal failure, infection
Classification by specialty	Medicine in general Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the pharmacokinetics and dialyzability of faropenem during hemodialysis
Basic objectives2	Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Hemodialysis clearance of faropenem
Key secondary outcomes

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	Medicine
Interventions/Control_1	To measure the concentration of faropenem, blood samples were collected from both the pre- and post-dialyzer lines before, and at 2 and 4 hr after hemodialysis.
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	1. Hemodialysis has been carried out due to chronic renal failure 2. Hemodialysis was carried out continuously for more than one month 3. Faropenem is adapted
Key exclusion criteria	1. Patients with poorly controlled diabetes (HbA1c 7.0% or more) 2. Patients with hepatic failure 3. Patients have a history of allergy to beta-lactam antibiotics 4. Patients have been taking faropenem within one week 5. Patients taking sodium valproate 6. Patients taking warfarin 7. Pregnant women and nursing woman 8. Judged inappropriate to participate in this study by a doctor
Target sample size	10

Research contact person
Name of lead principal investigator	Akio Fujimura
Organization	Jichi Medical University
Division name	Division of Clinical Pharmacology, Department of Pharmacology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7388
Email	akiofuji@jichi.ac.jp

Public contact
Name of contact person	Kentaro Ushijima
Organization	Jichi Medical University
Division name	Division of Clinical Pharmacology, Department of Pharmacology
Address	3311-1 Yakushiji, Shimotsuke, Tochigi
TEL	0285-58-7388
Homepage URL
Email	ushijima-kentarou@umin.ac.jp

Sponsor
Institute	Division of Clinical Pharmacology, Department of Pharmacology, Jichi Medical University
Institute
Department

Funding Source
Organization	Jichi Medical University
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

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

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	真岡病院（真岡市）、笠岡第一病院（笠岡市）

Other administrative information
Date of disclosure of the study information	2015 Year 10 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2006 Year 09 Month 05 Day
Anticipated trial start date	2006 Year 12 Month 11 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Published
URL releasing results	https://www.ncbi.nlm.nih.gov/pubmed/27629941
Results	The elimination ratio of faropenem by hemodialysis was small as about 20%; In the 29th Annual Meeting of the Japanese Society of Clinical Pharmacology and Therapeutics (Tokyo, Dec 4th -6th, 2008)
Other related information

Management information
Registered date	2015 Year 10 Month 15 Day
Last modified on	2017 Year 11 Month 15 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022181