UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002331 |
|---|---|
| Receipt number | R000002850 |
| Scientific Title | Comparison of hypercalcemia between lanthanum carbonate and calcium carbonate in hyperphosphatemia patients on dialysis; a cross-over study |
| Date of disclosure of the study information | 2009/08/17 |
| Last modified on | 2012/06/03 22:05:59 |
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Basic information
Public title
Comparison of hypercalcemia between lanthanum carbonate and calcium carbonate in hyperphosphatemia patients on dialysis; a cross-over study
Acronym
Comparison of hypercalcemia between lanthanum carbonate and calcium carbonate
Scientific Title
Comparison of hypercalcemia between lanthanum carbonate and calcium carbonate in hyperphosphatemia patients on dialysis; a cross-over study
Scientific Title:Acronym
Comparison of hypercalcemia between lanthanum carbonate and calcium carbonate
Region
| Japan |
Condition
Condition
Maintenance hemodialysis patients with hyperphosphatemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To compare the incidence of hypercalcemia between lanthanum carbonate and calcium carbonate treatments in hyperphosphatemia patients on hemodialysis by cross-over study.
Basic objectives2
Others
Basic objectives -Others
Inflammation markers
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
The incidence of hypercalcemia for 3 months between lanthanum carbonate and calcium carbonate treatments.
Key secondary outcomes
1. Serum phosphate, serum calcium and serum albumin
2. Adverse events
3. Inflammation markets
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Lanthanum carbonatet to Calcium carbonate
Interventions/Control_2
Calcium carbonate to Lanthanum carbonate
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
Hyperphosphatemia patients on hemodialysis (dialysis: more than 3 months) receiveing phosphate binders
Key exclusion criteria
1) Pts with cancer or suspicious for cancer, Pts with inflammatory disorder
2) Pts who meet the contraindiation criteria in package insert of lanthanum carbonate or calcium carbonate
3) Pregnant or possibly pregnant pts, pts on lactation
4) Inappropriate pts for this study according to the investigator's judgment
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shouichi Fujimoto |
Organization
University of Miyazaki hospital
Division name
Dialysis Division
Zip code
Address
5200 Kihara Kiyotake Miyazaki
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Tatsunori toida |
Organization
Chiyoda Hospital
Division name
Internal medicine
Zip code
Address
TEL
0982527111
Homepage URL
Sponsor or person
Institute
University of Miyazaki hospital
Institute
Department
Personal name
Funding Source
Organization
Dialysis Division, University of Miyazaki hospital
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
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 | 08 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
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 | 07 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2009 | Year | 08 | Month | 13 | Day |
Last modified on
| 2012 | Year | 06 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002850
