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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000009246
Receipt No. R000010856
Scientific Title Superiority of bixalomer (Kiklin) as phosphate binder and impact on lipid metabolism in HD patients (Skip-study)
Date of disclosure of the study information 2012/11/01
Last modified on 2014/02/17

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Basic information
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
Condition Hemodialysis patients with hyperphosphatemia
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
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

Assessment
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

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
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

Eligibility
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

Research contact person
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

Public contact
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

Sponsor
Institute Juntendo University Faculty of Medicine
Institute
Department

Funding Source
Organization Juntendo University Faculty of Medicine
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 順天堂医院(東京都)

Other administrative information
Date of disclosure of the study information
2012 Year 11 Month 01 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 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
Other related information

Management information
Registered date
2012 Year 11 Month 01 Day
Last modified on
2014 Year 02 Month 17 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000010856

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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