UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000006333 |
|---|---|
| Receipt number | R000007509 |
| Scientific Title | Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate and calcium carbonate on FGF23 in hemodialysis patients |
| Date of disclosure of the study information | 2011/09/15 |
| Last modified on | 2012/09/13 12:56:59 |
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Basic information
Public title
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate and calcium carbonate on FGF23 in hemodialysis patients
Acronym
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate and calcium carbonate on FGF23 in hemodialysis patients
Scientific Title
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate and calcium carbonate on FGF23 in hemodialysis patients
Scientific Title:Acronym
Randomized trial on the effect of non-calcium-containing phosphate binder lanthanum carbonate and calcium carbonate on FGF23 in hemodialysis patients
Region
| Japan |
Condition
Condition
Chronic kidney disease
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the effect of lanthanum carbonate and calcium carbonate on serum phosphate and FGF23 levels in newly initiated hemodialysis patients with hyperphosphatemia
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Change of serum FGF23 levels
Key secondary outcomes
Serum phosphate level achievement rate as defined by the JSDT guideline
Safety
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
NO
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonate treatment (Follow-up: 3 months)
Interventions/Control_2
Calcium carbonate treatment (Follow-up: 3 months)
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) Newly initiated hemodialysis patients for within 2 weeks
2) Age >20 years old
3) Patients with written IC
Key exclusion criteria
1) Malignancy of any type at enrollment
2) History of hypersensitivity to any of the ingredients of Lanthanum carbonate or Calcium carbonate
3) Severe hepatic dysfunction
4) Active digestive ulcer, ulcerative colitis, Crohn's disease and constriction of intestine
5) Pregnant or possibly pregnant women
6) Women on lactation
7) 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 | Yasuhiko Tomino |
Organization
Juntendo University Faculty of Medicine
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL
+81-3-3813-3111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Junichiro Nakata |
Organization
Juntendo University Faculty of Medicine
Division name
Division of Nephrology, Department of Internal Medicine
Zip code
Address
2-1-1 Hongo Bunkyo-ku, Tokyo, Japan
TEL
Homepage URL
jnakata@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2011 | Year | 09 | Month | 15 | 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 | 01 | 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
Management information
Registered date
| 2011 | Year | 09 | Month | 12 | Day |
Last modified on
| 2012 | Year | 09 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007509
| Research Plan | |
|---|---|
| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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