UMIN-CTR Clinical Trial

Basic information
Public title	The study on renal excretion drug dosage adjustment by point of care test in community pharmacy
Acronym	The study on proper use of medicine by point of care test in community pharmacy
Scientific Title	The study on renal excretion drug dosage adjustment by point of care test in community pharmacy
Scientific Title:Acronym	The study on proper use of medicine by point of care test in community pharmacy
Region	Japan

Condition
Condition	Herpes zoster, Chronic Kidney disease
Classification by specialty	Medicine in general Nephrology Geriatrics Dermatology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Pharmacokinetics are often altered in CKD patients.In particular, the optimal dosages of renally excreted drugs are strongly affected by renal impairment. Dosages that do not take renal function into account are a major cause of increases in drug blood concentrations that lead to adverse drug events. Appropriate dosages of renally excreted drugs can be calculated on the basis of renal function using creatinine clearance. Thus, dosage adjustment based on renal function contributes to a reduction in the incidence of adverse drug events in older patients and others with renal impairment. Adjustment of the drug dosage according to renal function (ADDR) by pharmacists, as a result of checking renal function and recommending alterations in their prescriptions, can prevent inappropriate dosages and thus reduce the incidence of the resulting adverse drug events. However, there is insufficient implementation of ADDR by community pharmacists and to check prescriptions for patients with renal impairment and to implement ADDR. In particular,most community pharmacists indicated that the most frequent obstacle to implementing ADDR was "Difficulty in obtaining information on patient renal function". The aims of this study were to investigate the efficacy of renal function point of care testing for prevention of renally excreted drugs overdose.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	The number of avoidance of renally excreted drugs overdose
Key secondary outcomes	Reduction of drug cost Frequency of adverse drug event

Base
Study type	Interventional

Study design
Basic design	Single arm
Randomization	Non-randomized
Randomization unit
Blinding	Open -no one is blinded
Control	Self control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms	1
Purpose of intervention	Prevention
Type of intervention	Medicine Other
Interventions/Control_1	Serum creatinine point of care testing
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	The patients over 65 and/or had suspection of renal insufficiency The patients are prescribed aciclovir, valaciclovir, or famciclovir
Key exclusion criteria	Dialysis patient The patients taking anticoagulants The patients are prone to bleeding The patients who are unable to self-collect the blood sample
Target sample size	100

Research contact person
Name of lead principal investigator	1st name Middle name Last name Yuki Kondo
Organization	Graduate School of Pharmaceutical Sciences, Kumamoto University
Division name	Department of Clinical Chemistry and Informatics
Zip code
Address	5-1 Oe-honmachi, Chuo-ku, Kumamoto, Japan
TEL	096-371-4559
Email	ykondo@kumamoto-u.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Yuki Kondo
Organization	Graduate School of Pharmaceutical Sciences, Kumamoto University
Division name	Department of Clinical Chemistry and Informatics
Zip code
Address	5-1 Oe-honmachi, Chuo-ku, Kumamoto, Japan
TEL	096-371-4559
Homepage URL
Email	ykondo@kumamoto-u.ac.jp

Sponsor
Institute	Kumamoto University
Institute
Department

Funding Source
Organization	Kumamoto University
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

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	託麻中央薬局（熊本県）

Other administrative information
Date of disclosure of the study information	2016 Year 10 Month 01 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	2016 Year 04 Month 01 Day
Date of IRB	2015 Year 11 Month 26 Day
Anticipated trial start date	2016 Year 10 Month 01 Day
Last follow-up date	2019 Year 04 Month 01 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2016 Year 09 Month 26 Day
Last modified on	2019 Year 04 Month 01 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023451

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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