UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006627 |
|---|---|
| Receipt number | R000007794 |
| Scientific Title | Systematic action of instruction on the use of lanthanum carbonate by the pharmacists improves a serum phosphorus levels |
| Date of disclosure of the study information | 2011/10/28 |
| Last modified on | 2012/05/31 21:42:35 |
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Basic information
Public title
Systematic action of instruction on the use of lanthanum carbonate by the pharmacists improves a serum phosphorus levels
Acronym
Influence on the serum phosphorus levels by the explicit pharmacist's instruction.
Scientific Title
Systematic action of instruction on the use of lanthanum carbonate by the pharmacists improves a serum phosphorus levels
Scientific Title:Acronym
Influence on the serum phosphorus levels by the explicit pharmacist's instruction.
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Fosrenol is a chewable tablet which is prescribed as anti-hyperphosphatemia. In order to acquire the effect as a phosphate binder, patients are recommended to chew Fosrenol tablets completely before swallowing. And patient's understanding of medication is reflected in an expected effect. Then, examine the influence of instruction on the use of Fosrenol by the pharmacists to patients on performing the check of an understanding of medicine, and the right taking method whether it leads to further improvement of serum phosphorus control and adherence improvement.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Serum P level
Key secondary outcomes
Serum Ca level
i-PTH level
intake of phosphorus per day
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
1)Hemodialysis patients who have been taking Fosrenol Chewble Tablets at least 4 weeks.
2)Average Serum P >3.5 mg/dL in the nearest 12 weeks.
3)Outpatient
Key exclusion criteria
Patients will not be eligible for the study of they meet any of the following criteria.:
1)Patients who patient compliance instruction is difficult by the reason of dementia or others.
2)Patients by whom inpatient treatment is planned during study period.
3)Ineligible patients according to the investigator's judgment.
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hirayama Hitomi |
Organization
Ikegami general hospital
Division name
Department of pharmacy
Zip code
Address
6-1-19 Ikegami,Ota-ku, Tokyo, Japan
TEL
+81-3-3752-3151
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hirayama Hitomi |
Organization
Ikegami general hospital
Division name
Department of pharmacy
Zip code
Address
6-1-19 Ikegami,Ota-ku, Tokyo, Japan
TEL
+81-3-3752-3151
Homepage URL
ebiebi33@gmail.com
Sponsor or person
Institute
Ikegami general hospital
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
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
池上総合病院（東京都） Ikegami general hospital
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 10 | Month | 28 | 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
| 2011 | Year | 08 | Month | 11 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 08 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
hyperphosphatemia
pharmacist's instruction
adherence
prospective study
Management information
Registered date
| 2011 | Year | 10 | Month | 28 | Day |
Last modified on
| 2012 | Year | 05 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007794
| 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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