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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000006627
Receipt No. 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

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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
Email

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
Email ebiebi33@gmail.com

Sponsor
Institute Ikegami general hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007794

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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