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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000005089
Receipt No. R000006051
Scientific Title Diagnostic research on renal OAT1 function using Tc-MAG3
Date of disclosure of the study information 2011/02/15
Last modified on 2015/03/18

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Basic information
Public title Diagnostic research on renal OAT1 function using Tc-MAG3
Acronym Diagnostic research on renal OAT1 function
Scientific Title Diagnostic research on renal OAT1 function using Tc-MAG3
Scientific Title:Acronym Diagnostic research on renal OAT1 function
Region
Japan

Condition
Condition Healthy volunteers
Classification by specialty
Adult
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether Tc-MAG3 is suitable for clinical application as a selective substrate of renal tubular epithelial OAT1, and to clinically assess the utility of Tc-MAG3 as the new functional diagnostic probe for OAT1.
Basic objectives2 Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Difference in parameters on excretion rate between control and drug loading conditions (OAT1+OAT3 or OAT1 affinity drug)
Key secondary outcomes

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Diagnosis
Type of intervention
Medicine
Interventions/Control_1 Probenecid loadng
Interventions/Control_2 para-aminohippuric acid (PAH) loading
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
30 years-old >
Gender Male
Key inclusion criteria Healthy volunteers
Key exclusion criteria Mental disease or other serious physical disorders in the past or at the present
Target sample size 12

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Yasuhisa Fujibayashi
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa Inage, Chiba
TEL 043-206-3423
Email yfuji@nirs.go.jp

Public contact
Name of contact person
1st name
Middle name
Last name Tsuneo Saga
Organization National Institute of Radiological Sciences
Division name Molecular Imaging Center
Zip code
Address 4-9-1 Anagawa Inage, Chiba
TEL 043-206-3421
Homepage URL
Email saga@nirs.go.jp

Sponsor
Institute National Institute of Radiological Sciences
Institute
Department

Funding Source
Organization National Institute of Radiological Sciences
Organization
Division
Category of Funding Organization Other
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

Other administrative information
Date of disclosure of the study information
2011 Year 02 Month 15 Day

Related information
URL releasing protocol
Publication of results Published

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 02 Month 02 Day
Date of IRB
Anticipated trial start date
2011 Year 03 Month 01 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
2011 Year 02 Month 15 Day
Last modified on
2015 Year 03 Month 18 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006051

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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