UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002058 |
|---|---|
| Receipt number | 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 16:22:14 |
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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
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
fukagawa@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe University 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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002512
