UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019365 |
|---|---|
| Receipt number | R000022181 |
| Scientific Title | Dialyzability of faropenem sodium during hemodialysis in patients with chronic renal failure |
| Date of disclosure of the study information | 2015/10/17 |
| Last modified on | 2017/11/15 09:47:04 |
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Basic information
Public title
Dialyzability of faropenem sodium during hemodialysis in patients with chronic renal failure
Acronym
Dialyzability of faropenem sodium during hemodialysis
Scientific Title
Dialyzability of faropenem sodium during hemodialysis in patients with chronic renal failure
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Akio Fujimura |
Organization
Jichi Medical University
Division name
Division of Clinical Pharmacology, Department of Pharmacology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7388
akiofuji@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kentaro Ushijima |
Organization
Jichi Medical University
Division name
Division of Clinical Pharmacology, Department of Pharmacology
Zip code
Address
3311-1 Yakushiji, Shimotsuke, Tochigi
TEL
0285-58-7388
Homepage URL
ushijima-kentarou@umin.ac.jp
Sponsor or person
Institute
Division of Clinical Pharmacology, Department of Pharmacology, Jichi Medical University
Institute
Department
Personal name
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)
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
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 |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
https://www.ncbi.nlm.nih.gov/pubmed/27629941
Number of participants that the trial has enrolled
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)
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
Completed
Date of protocol fixation
| 2006 | Year | 09 | Month | 05 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022181
