UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000024171 |
|---|---|
| Receipt number | R000023451 |
| Scientific Title | The study on renal excretion drug dosage adjustment by point of care test in community pharmacy |
| Date of disclosure of the study information | 2016/10/01 |
| Last modified on | 2019/04/01 10:40:19 |
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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
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
ykondo@kumamoto-u.ac.jp
Sponsor or person
Institute
Kumamoto University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023451
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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