UMIN-CTR Clinical Trial

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

endstage kidney disease on hemodialysis

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

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

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

Study type

Interventional

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

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

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 ofinstitution) 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

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

Zip code

Address

8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5269-7354

Email

takiba@kc.twmu.ac.jp

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

Zip code

Address

8-1 Kawadacho, Shinjuku-ku, Tokyo, Japan

TEL

+81-3-5269-7354

Homepage URL

Email

takiba@kc.twmu.ac.jp

Institute

CKD-MBD Clinical Study Group

Institute

Department

Personal name

Organization

Astellas Pharma Inc.

Organization

Division

Category of Funding Organization

Profit organization

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

東京女子医科大学病院（東京都）

Date of disclosure of the study information

2014

Year

02

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

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

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

13

Day

Last follow-up date

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2014

Year

02

Month

13

Day

Last modified on

2014

Year

02

Month

13

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000015330