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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007234
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute Tokyo Women's Medical University Hospital
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
Address
Tel
Email

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008526

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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