UMIN-CTR Clinical Trial

Public title

Superiority of bixalomer (Kiklin) as phosphate binder and impact on lipid metabolism in HD patients (Skip-study)

Acronym

Superiority of bixalomer (Kiklin) as phosphate binder and impact on lipid metabolism in HD patients (Skip-study)

Scientific Title

Superiority of bixalomer (Kiklin) as phosphate binder and impact on lipid metabolism in HD patients (Skip-study)

Scientific Title:Acronym

Superiority of bixalomer (Kiklin) as phosphate binder and impact on lipid metabolism in HD patients (Skip-study)

Region

Japan

Condition

Hemodialysis patients with hyperphosphatemia

Classification by specialty

Nephrology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

Comparisons of the improvement of phosphate and lipid metabolism and adverse effects on digestive symptoms between sevelamer and Bixalomer

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Confirmatory

Trial characteristics_2

Pragmatic

Developmental phase

Not applicable

Primary outcomes

Serum phosphorus concentrations

Key secondary outcomes

Evaluation of efficacy
1.Lipid metabolism:T-Cho,TG,HDL-C,RLP-C
2.Blood gas concentrations
3.Abdominal symptoms evaluation
4.Drug remedy time estimation
5.Adverse events

Study type

Interventional

Basic design

Single arm

Randomization

Non-randomized

Randomization unit

Blinding

Open -no one is blinded

Control

Uncontrolled

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

1)Bixalomer :The present study will start after the agreement from participants immediately. The initial dose of bixalomer is 500mg just before each meal, then requires an appropriate addition of bixalomer to reach the optimum serum phospate. The maximum dailly dose of bixalomer is 7,500mg.

Interventions/Control_2

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

Not applicable

Age-upper limit

Not applicable

Gender

Male and Female

Key inclusion criteria

Patients are eligible if they are compatible with the following criteria.
1,hemodialysis patients complicated with hyperphosphorous who treated with sevelamar hydrochloride.
2,30 patients with agreement for exchange from sevelamer to bixalomer as phosphate-binder.
3,Patients who is available for the record to questionnaires (an abdominal symptom, medication situation questionnaire).
4,Patients who we agreed with the participation of the study based on informed consent before the study initiation, and filled in signature sealing or a signature and a date

Key exclusion criteria

Patients are excluded if they are compatible with any one of the following criteria.
1,Patients with a history of hypersensitivity for an ingredient of this medicine
2,Patients with bowel obstruction (for a non-absorbable polymer, we might raise intestinal perforation)
3,Patients with significant psychic disturbance or drug dependence disease or alcoholism
4,Patients that going to hospital of all follow-up seems to be impossible
5,Patients who are not able to understand a test instructions from medical experts of the client side or the doctors involved in the study
6,Patients who judged as inadequate by the doctors involved in the study

Target sample size

30

Name of lead principal investigator

1st name
Middle name
Last name	Yasuhiko Tomino

Organization

Juntendo University Faculty of Medicine

Division name

Department of Internal Medicine, Division of Nephrology

Zip code

Address

Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan

TEL

03-3813-1183

Email

yasu@juntenedo.ac.jp

Name of contact person

1st name
Middle name
Last name	Chieko Hamada

Organization

Juntendo University Faculty of Medicine

Division name

Department of Internal Medicine, Division of Nephrology

Zip code

Address

Hongo 3-1-3, Bunkyo-ku,Tokyo 113-8421,Japan

TEL

03-3813-3111

Homepage URL

Email

chieko@juntendo.ac.jp

Institute

Juntendo University Faculty of Medicine

Institute

Department

Personal name

Organization

Juntendo University Faculty of Medicine

Organization

Division

Category of Funding Organization

Other

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

順天堂医院（東京都）

Date of disclosure of the study information

2012

Year

11

Month

01

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

Completed

Date of protocol fixation

2012

Year

10

Month

19

Day

Date of IRB

Anticipated trial start date

2012

Year

10

Month

19

Day

Last follow-up date

2013

Year

03

Month

31

Day

Date of closure to data entry

2013

Year

03

Month

31

Day

Date trial data considered complete

2013

Year

03

Month

31

Day

Date analysis concluded

2013

Year

12

Month

31

Day

Other related information

Registered date

2012

Year

11

Month

01

Day

Last modified on

2014

Year

02

Month

17

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010856