UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007234 |
|---|---|
| Receipt number | R000008526 |
| Scientific Title | The study of finding appropriate usage/dosage of peramivir on hemodialysis patient, an open-label study. |
| Date of disclosure of the study information | 2012/02/06 |
| Last modified on | 2012/06/27 11:49:36 |
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Basic information
Public title
The study of finding appropriate usage/dosage of peramivir on hemodialysis patient, an open-label study.
Acronym
The study of finding appropriate usage/dosage of peramivir on hemodialysis patient, an open-label study.
Scientific Title
The study of finding appropriate usage/dosage of peramivir on hemodialysis patient, an open-label study.
Scientific Title:Acronym
The study of finding appropriate usage/dosage of peramivir on hemodialysis patient, an open-label study.
Region
| Japan |
Condition
Condition
hemodialysis patient
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the appropriate usage/dosage of peramivir by PK/PD in hemodialysis patient.
Basic objectives2
PK,PD
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
To evaluate the appropriate usage/dosage of peramivir.
Key secondary outcomes
None
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 | Other |
Interventions/Control_1
Medication, Blood sampling for PK/PD
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) Patients with informed consent.
2) Age:over 20 years ( at the time the informed consent form is signed )
3) Gender: Male or female, In patients or Out patients.
4) Patients with regularly hemodialyzed.
5) Patients without influenza virus.
Key exclusion criteria
1) History of hypersensitivity, allergy or serious adverse drug event caused by oseltamivir phosphate, zanamivir hydrate, peramivir hydrate or raninanivir.
2)Patient with contraindications of 1) drugs.
3)Hepatic disorder.
4) Women who are pregnant or suspected to be pregnant and women who are breast-feeding.
5) Any other patients whose condition is inappropriate for the evaluation of this clinical study as judged by the investigator.
Target sample size
6
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Takashi Akiba |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Bloods Purification, Kidney Center
Zip code
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Takashi Akiba |
Organization
Tokyo Women's Medical University Hospital
Division name
Department of Bloods Purification, Kidney Center
Zip code
Address
8-1, Kawadacho, Shinjuku-ku, Tokyo, 162-8666, Japan
TEL
Homepage URL
Sponsor or person
Institute
Tokyo Women's Medical University Hospital
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
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
東京女子医科大学病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2012 | Year | 02 | Month | 06 | 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
| 2011 | Year | 10 | Month | 26 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 04 | Month | 01 | Day |
Date of closure to data entry
| 2012 | Year | 06 | Month | 01 | Day |
Date trial data considered complete
| 2012 | Year | 06 | Month | 01 | Day |
Date analysis concluded
| 2012 | Year | 07 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 06 | Day |
Last modified on
| 2012 | Year | 06 | Month | 27 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008526
| 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 |
