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UMIN-CTR Clinical Trial |
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Name: | UMIN ID: |
Recruitment status | Completed |
Unique ID issued by UMIN | UMIN000024171 |
Receipt No. | 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 |
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 |
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Condition | |||||
Condition | Herpes zoster, Chronic Kidney disease | ||||
Classification by specialty |
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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 |
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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 |
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Age-upper limit |
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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 |
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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 |
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Target sample size | 100 |
Research contact person | |||||||
Name of lead principal investigator |
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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 |
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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 | |
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 | |
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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 |
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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 |
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Date of IRB |
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Anticipated trial start date |
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Last follow-up date |
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Date of closure to data entry | |||||||
Date trial data considered complete | |||||||
Date analysis concluded |
Other | |
Other related information |
Management information | |||||||
Registered date |
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Last modified on |
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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 |