UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Evaluation of Pharmacists Intervention for the prevention of occurrence of kidney toxicity during vancomycin usage
Title of the study (Brief title)	Evaluation of Pharmacists Intervention for the prevention of occurrence of kidney toxicity during vancomycin usage
Region	Japan

Condition
Condition	kidney toxicity on using vancomycin
Classification by specialty	Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	TBD
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	TBD
Key secondary outcomes

Base
Study type	Interventional

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

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Medicine
Interventions/Control_1	Pharmacists intervention
Interventions/Control_2	Conventional therapy
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	TBD
Key exclusion criteria	TBD
Target sample size	600

Research contact person
Name of lead principal investigator	Daisuke Teshima
Organization	Shujitsu university
Division name	Department of pharmacy
Address	1-6-1, Nishigawara, Okayama city, Okayama prefecture, Japan
TEL	086-271-8111
Email	akohmoto-tky@umin.ac.jp

Public contact
Name of contact person	TBD
Organization	TBD
Division name	TBD
Address	TBD
TEL	086-271-8111
Homepage URL
Email	akohmoto-tky@umin.ac.jp

Sponsor
Institute	TBD
Institute
Department

Funding Source
Organization	TBD
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2014 Year 05 Month 31 Day
Anticipated trial start date	2014 Year 06 Month 30 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2014 Year 09 Month 25 Day
Last modified on	2018 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017739