UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000005089 |
|---|---|
| Receipt number | 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 09:17:50 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
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
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
saga@nirs.go.jp
Sponsor or person
Institute
National Institute of Radiological Sciences
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000006051
