UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000013146
Receipt number 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 19:29:52

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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 or person

Institute

CKD-MBD Clinical Study Group

Institute

Department

Personal name



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

Value
https://center6.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