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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002331
Receipt No. 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

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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
Email

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
Email

Sponsor
Institute University of Miyazaki hospital
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000002850

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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