UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000018615 |
|---|---|
| Receipt number | R000021493 |
| Scientific Title | Comparison between plasma mycophenolic acid concentrations determined by liquid chromatography-tandem mass spectrometry and particle-enhanced turbidimetric inhibition immunoassay methods |
| Date of disclosure of the study information | 2015/08/10 |
| Last modified on | 2016/02/10 12:59:14 |
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Basic information
Public title
Comparison between plasma mycophenolic acid concentrations determined by liquid chromatography-tandem mass spectrometry and particle-enhanced turbidimetric inhibition immunoassay methods
Acronym
Comparison between plasma mycophenolic acid concentrations determined by liquid chromatography-tandem mass spectrometry and particle-enhanced turbidimetric inhibition immunoassay methods
Scientific Title
Comparison between plasma mycophenolic acid concentrations determined by liquid chromatography-tandem mass spectrometry and particle-enhanced turbidimetric inhibition immunoassay methods
Scientific Title:Acronym
Comparison between plasma mycophenolic acid concentrations determined by liquid chromatography-tandem mass spectrometry and particle-enhanced turbidimetric inhibition immunoassay methods
Region
| Japan |
Condition
Condition
lung transplantation
Classification by specialty
| Chest surgery | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The plasma mycophenolic acid concentrations determined by LC/MS/MS and PETINIA methods will be compared. The equivalency is confirmed.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The equivalency of plasma mycophenolic acid concentration
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
After lung transplant surgery
In hospital
The plasma mycophenolic acid concentration is measured by LC/MS/MS method
Key exclusion criteria
No
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Nariyasu Mano |
Organization
Tohoku university hospital
Division name
Department of pharmaceutical sciences
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL
022-717-7525
mano@hosp.tohoku.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroaki Yamaguchi |
Organization
Tohoku university hospital
Division name
Department of pharmaceutical sciences
Zip code
Address
1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL
022-717-7528
Homepage URL
yamaguchi@hosp.tohoku.ac.jp
Sponsor or person
Institute
Department of pharmaceutical sciences, Tohoku university hospital
Institute
Department
Personal name
Funding Source
Organization
Management expenses grants
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of thoracic therapy, Tohoku university hospital
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
東北大学病院（宮城県）
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 08 | Month | 10 | 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
| 2015 | Year | 06 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 07 | 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
The plasma mycophenolic acid concentrations determined by LC/MS/MS and PETINIA methods will be compared. The equivalency is confirmed.
Management information
Registered date
| 2015 | Year | 08 | Month | 10 | Day |
Last modified on
| 2016 | Year | 02 | Month | 10 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000021493
| 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 |
