UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Measurement of plasma mycophenolic acid concentration using dried blood spot method.
Title of the study (Brief title)	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	Nariyasu Mano
Organization	Tohoku university hospital
Division name	Department of pharmaceutical sciences
Address	1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL	022-717-7525
Email	mano@hosp.tohoku.ac.jp

Public contact
Name of contact person	Hiroaki Yamaguchi
Organization	Tohoku university hospital
Division name	Department of pharmaceutical sciences
Address	1-1 Seiryo-machi, Aoba-ku, Sendai-city, Miyagi
TEL	022-717-7528
Homepage URL
Email	yamaguchi@hosp.tohoku.ac.jp

Sponsor
Institute	Department of pharmaceutical sciences, Tohoku university hospital
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 27 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022587