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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002058
Receipt No. R000002512
Scientific Title Effect of lanthanum carbonate on medical cost and laboratory values in hemodialysis patients with hyperphosphatemia
Date of disclosure of the study information 2009/07/01
Last modified on 2010/06/10

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Basic information
Public title Effect of lanthanum carbonate on medical cost and laboratory values in hemodialysis patients with hyperphosphatemia
Acronym Effect of lanthanum carbonate on medical cost and laboratory values
Scientific Title Effect of lanthanum carbonate on medical cost and laboratory values in hemodialysis patients with hyperphosphatemia
Scientific Title:Acronym Effect of lanthanum carbonate on medical cost and laboratory values
Region
Japan

Condition
Condition Hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To assess the effect of lanthanum carbonate as an additive treatment on medical cost.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes 1, Change in phosphate, calcium, and parathyroid hormone before and after lanthanum carbonate treatment.
2, Change in the dose of calcium containing phosphate binder, sevelamer, vitamin D analogues, and cinacalcet.
3, Medical cost of lanthanum carbonate
Key secondary outcomes Side effect of lanthanum carbonate

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
18 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria The hemodialysis outpatients who can't control serum phosphate with conventional treatment.
Key exclusion criteria 1, The patients who don't agree with this study
2, The patients who are judged inappropriate for the study by the physician
Target sample size 150

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Masafumi Fukagawa
Organization Kobe University Graduate School of Medicine
Division name Division of Nephrology and Kidney Center
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Masafumi Fukagawa
Organization Kobe University Graduate School of Medicine
Division name Division of Nephrology and Kidney Center
Zip code
Address 7-5-2, Kusunoki-cho, Chuo-ku, Kobe 650-0017
TEL 078-382-6500
Homepage URL
Email fukagawa@med.kobe-u.ac.jp

Sponsor
Institute Kobe University 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

Other administrative information
Date of disclosure of the study information
2009 Year 07 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
2009 Year 04 Month 06 Day
Date of IRB
Anticipated trial start date
2009 Year 05 Month 01 Day
Last follow-up date
2010 Year 01 Month 01 Day
Date of closure to data entry
2010 Year 02 Month 01 Day
Date trial data considered complete
2010 Year 02 Month 01 Day
Date analysis concluded
2010 Year 04 Month 01 Day

Other
Other related information 1, To assess the effect of lanthanum carbonate as an additive treatment on medical cost.
2, Prospective cohort study

Management information
Registered date
2009 Year 06 Month 10 Day
Last modified on
2010 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002512

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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