UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019531 |
|---|---|
| Receipt number | R000022587 |
| Scientific Title | Measurement of plasma mycophenolic acid concentration using dried blood spot method. |
| Date of disclosure of the study information | 2015/10/28 |
| Last modified on | 2018/10/30 13:01:25 |
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Basic information
Public title
Measurement of plasma mycophenolic acid concentration using dried blood spot method.
Acronym
Measurement of plasma mycophenolic acid concentration using dried blood spot method.
Scientific Title
Measurement of plasma mycophenolic acid concentration using dried blood spot method.
Scientific Title:Acronym
Measurement of plasma mycophenolic acid concentration using dried blood spot method.
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 using dried blood spot methods and conventional pretreatment 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
Japanese Governmental office
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Department of thoracic therapy, Tohoku university hospital
Name of secondary funder(s)
Shimadzu Corporation
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
| 2015 | Year | 10 | Month | 28 | 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 | 10 | Month | 27 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 10 | Month | 27 | Day |
Last follow-up date
| 2018 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2018 | Year | 05 | Month | 31 | Day |
Date trial data considered complete
| 2018 | Year | 05 | Month | 31 | Day |
Date analysis concluded
| 2018 | Year | 05 | Month | 31 | Day |
Other
Other related information
Patients who were admitted to our hospital, met the selection criteria on or after October 27, 2015
Management information
Registered date
| 2015 | Year | 10 | Month | 28 | Day |
Last modified on
| 2018 | Year | 10 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022587
| 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 |
