UMIN-ICDS Clinical Trial
| Unique ID issued by UMIN | UMIN000049814 |
|---|---|
| Receipt number | R000056737 |
| Scientific Title | Evaluation of efficacy of the community pharmacy intervention to optimize serum potassium levels in patients with chronic kidney disease |
| Date of disclosure of the study information | 2022/12/18 |
| Last modified on | 2023/12/20 08:26:15 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Evaluation of efficacy of the community pharmacy intervention to optimize serum potassium levels in patients with chronic kidney disease
Acronym
Investigating the efficacy of community pharmacy intervention on serum potassium levels in patients with chronic kidney disease
Scientific Title
Evaluation of efficacy of the community pharmacy intervention to optimize serum potassium levels in patients with chronic kidney disease
Scientific Title:Acronym
Investigating the efficacy of community pharmacy intervention on serum potassium levels in patients with chronic kidney disease
Region
| Japan |
Condition
Condition
chronic kidney disease
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the effect of a few minutes of dietary conunseling on serum potassium levels by a pharmacy pharmacist in addition to traditional medication instruction in patients with chronic kidney disease.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
The primary endpoints is the changes in serum potassium levels before and after the intervention.
Key secondary outcomes
The secondary endpoint is the change in patients' attitudes toward potassium restriction.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Numbered container method
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Behavior,custom |
Interventions/Control_1
Nutrition counseling: Provide one nutritional guidance session at the time of visit to the office with written instructions on diet therapy.
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
| 18 | years-old | <= |
Age-upper limit
| 100 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patients with estimated glomerular filtration rate less than 45 mL/min/1.73 m2 attending National Hospital Organization Mie Chuo Medical Center
Key exclusion criteria
1) Patients who do not agree to participate in this study
2) Patients with communication difficulties
3) Patients with hypokalemia (serum potassium level less than 4.0 mmol/L)
4) Patients on maintenance dialysis
5) Patients who bring refill prescriptions
6) Patients taking oral potassium preparations
7) Patients who are not expected to continuously visit the insurance pharmacy under study for at least 3 months
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yuki |
| Middle name | |
| Last name | Asai |
Organization
National Hospital Organization Mie Chuo Medical Center
Division name
Pharmacy
Zip code
514-1101
Address
2158-5 Hisaimyojin, Tsu, Mie
TEL
059-259-1211
yuki0715asai@gmail.com
Public contact
Name of contact person
| 1st name | Yuki |
| Middle name | |
| Last name | Asai |
Organization
National Hospital Organization Mie Chuo Medical Center
Division name
Pharmacy
Zip code
514-1101
Address
2158-5 Hisaimyojin, Tsu, Mie
TEL
059-259-1211
Homepage URL
yuki0715asai@gmail.com
Sponsor or person
Institute
National Hospital Organization Mie Chuo Medical Center
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Mie Pharmaceutical Association
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Mie Chuo Medical Cente (Clinical Research Department)
Address
2158-5 Hisaimyojin, Tsu, Mie
Tel
059-259-1211
yuki0715asai@gmail.com
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
国立病院機構三重中央医療センター（三重県）
Other administrative information
Date of disclosure of the study information
| 2022 | Year | 12 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2022 | Year | 11 | Month | 24 | Day |
Date of IRB
| 2022 | Year | 11 | Month | 24 | Day |
Anticipated trial start date
| 2022 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2023 | Year | 05 | Month | 31 | Day |
Date of closure to data entry
| 2023 | Year | 07 | Month | 31 | Day |
Date trial data considered complete
Date analysis concluded
| 2023 | Year | 12 | Month | 20 | Day |
Other
Other related information
Management information
Registered date
| 2022 | Year | 12 | Month | 18 | Day |
Last modified on
| 2023 | Year | 12 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000056737
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
