UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006610 |
|---|---|
| Receipt number | R000005771 |
| Scientific Title | Dialyzability of Sitafloxacin |
| Date of disclosure of the study information | 2012/10/01 |
| Last modified on | 2012/04/25 12:33:28 |
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Basic information
Public title
Dialyzability of Sitafloxacin
Acronym
Dialyzability of Sitafloxacin
Scientific Title
Dialyzability of Sitafloxacin
Scientific Title:Acronym
Dialyzability of Sitafloxacin
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine dialyzer clearance of levofloxacin
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
determine dialyzer clearance of sitafloxacin
Key secondary outcomes
elimination fraction and elimination halflife of sitafloxacin
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
Diagnosis
Type of intervention
| Device,equipment |
Interventions/Control_1
Four serial blood sampling during single session of hemodialysis.
Volume of a blood sampling: 2.5 to 7 ml
Total volume of blood: 19ml per patient
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) Stable hemodialysis patients with polysulfone dialyzer at Tsukuba Univ. Hospital, Ibaraki or Moka Hosputal, Tochigi Japan.
2) Patients whoe were prescribed sitafloxacin due to bronchitis, pneumonia or pyelonephritis.
3) Patients who gaved written informed consent.
Key exclusion criteria
1) Anemia (Hb<9mg/dl)
2) severe hepatic dysfunction (AST 3 times higher than upper normal limit of the insitution.
3)pregnant
4)allergic reaction to levofloxacin
5) history of epilepsy
6) Patients resercher regarded as not suitable
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kunihiro Yamagata |
Organization
Tsukuba University Hospital
Division name
Nephrology
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3202
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shuichi Tsuruoka |
Organization
Tsukuba University Hospital
Division name
Nephrology
Zip code
Address
2-1-1 Amakubo, Tsukuba, Ibaraki, Japan
TEL
029-853-3202
Homepage URL
tsuru@md.tsukuba.ac.jp
Sponsor or person
Institute
Department of Nephrology, Tsukuba University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Nephrology, Tsukuba University Hospital
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
筑波大学付属病院（茨城県）
真岡病院（栃木県）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 10 | Month | 01 | 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
Completed
Date of protocol fixation
| 2009 | Year | 07 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 01 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 05 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 12 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2011 | Year | 10 | Month | 25 | Day |
Last modified on
| 2012 | Year | 04 | Month | 25 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000005771
