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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000013146
Receipt No. R000015325
Scientific Title Bixalomer versus calcium carbonate on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a randomized study.
Date of disclosure of the study information 2016/02/12
Last modified on 2014/02/12

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Basic information
Public title Bixalomer versus calcium carbonate on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a randomized study.
Acronym BICOLOR STUDY
Scientific Title Bixalomer versus calcium carbonate on coronary artery calcification in hemodialysis patients with hyperphosphatemia: a randomized study.
Scientific Title:Acronym BICOLOR STUDY
Region
Japan

Condition
Condition endstage kidney disease on hemodialysis
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To compare the effect of bixalomer versus calcium carbonate on coronary artery calcification in 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 in coronary artery calcification score (CACs) by multi-detector CT
Key secondary outcomes 1. Change in serum phosphate and corrected serum calcium
2. Change in intact PTH
3. Change in serum FGF23
4. Change in serum alfa-Klotho
5. Change in serum pentosidine
6. Change in serum hs-CRP
7. Change in serum LDL-C
8. Change in serum NT-proBNP
9. cardiovascular event-free survival rate

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Open -but assessor(s) are blinded
Control Active
Stratification YES
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Bixalomer treatment (Follow-up: a year)
Interventions/Control_2 Calcium carbonate treatment (Follow-up: a year)
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)Patients with chronic kidney disease on hemodialysis who have been receiving calcium carbonate treatment for more than 3 months
2)Age 20 years or older at the time of giving informed consent
3)Ability to give written informed consent
Key exclusion criteria 1.Serum phosphate level 8.0mg/dL or more
2.Bowel obstruction
3. Severe chronic constipation or diarrhea
4. A history of gastrointestinal ulcer or bowel resection
5. Hypothyroidism
6. Severe cardiac disease (NYHA classification III-IV or wide range of old myocardial infarction)
7. A history of hospitalization for cerebrovascular or cardiovascular disease within a month
8. Liver dysfunction (AST or ALT more than 2-times the upper limit of institution, or T-Bil more than 1.5-times the upper limit of institution) or severe liver disorders (active chronic hepatitis)
9. Pregnant, women on lactation or possibly pregnant women, or plan to get pregnant during the study
10. Having a disadvantage for CT scan (pacemaker, artificial valve, coronary artery stent, atrial fibrillation, etc.)
11. Ineligible patients according to the investigator's judgment
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takashi Akiba
Organization Tokyo Women's Medical University
Division name Department of Blood Purification, Kidney Center
Zip code
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL +81-3-5269-7354
Email takiba@kc.twmu.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Takashi Akiba
Organization Tokyo Women's Medical University
Division name Department of Blood Purification, Kidney Center
Zip code
Address 8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan
TEL +81-3-5269-7354
Homepage URL
Email takiba@kc.twmu.ac.jp

Sponsor
Institute CKD-MBD Clinical Study Group
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
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 東京女子医科大学病院(東京都)

Other administrative information
Date of disclosure of the study information
2016 Year 02 Month 12 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 Enrolling by invitation
Date of protocol fixation
2014 Year 01 Month 17 Day
Date of IRB
Anticipated trial start date
2014 Year 02 Month 12 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
2014 Year 02 Month 12 Day
Last modified on
2014 Year 02 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015325

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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