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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000010671
Receipt No. R000012478
Scientific Title Efficacy and tolerability of bixalomer for treatment of hyperphosphatemia in maintenance hemodialysis patients with poor tolerance to sevelamer: a switching study.
Date of disclosure of the study information 2013/05/09
Last modified on 2014/06/16

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Basic information
Public title Efficacy and tolerability of bixalomer for treatment of hyperphosphatemia in maintenance hemodialysis patients with poor tolerance to sevelamer: a switching study.
Acronym Bixalomer for treatment of hyperphosphatemia in patients with poor tolerance to sevelamer: a switching study
(BIXA-SWITCH Study)
Scientific Title Efficacy and tolerability of bixalomer for treatment of hyperphosphatemia in maintenance hemodialysis patients with poor tolerance to sevelamer: a switching study.
Scientific Title:Acronym Bixalomer for treatment of hyperphosphatemia in patients with poor tolerance to sevelamer: a switching study
(BIXA-SWITCH Study)
Region
Japan

Condition
Condition Chronic renal failure
Classification by specialty
Medicine in general Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate the effect of bixalomer on serum phosphorus level and the adverse effects on digestive symptoms in hemodialysis patients with poor tolerance to sevelamer.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in the serum phosphorus level over the 12 weeks
Key secondary outcomes 1)Changes in digestive symptoms over the 12 weeks (assessed with the Izumo scale questionnaire)
2)Changes in medications for astriction
3)The dose of bixalomer which reaches the same level of serum phosphorus as that of sevelamer hydrochloride did before switch to bixalomer
4)Changes in a dose of bixalomer over the 12 weeks
5)Changes in a dose of calcium carbonate over the 12 weeks
6)Changes in the serum phosphorus level over the 4 weeks prior to bixalomer initiation and the last 4 weeks of the observational period (8-12 weeks after initiation)

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 Patients on sevelamer are to switch to bixalomer (dosed at 1500-7500 mg a day), and their serum phosphorus level is to be controlled by bixalomer.
*For those who meet the Case 1 in the inclusion criteria

Patients who discontinued sevelamer before and have been on another medication for hyperphosphatemia are to switch to bixalomer (dosed at 1500-7500 mg a day), and their serum phosphorus level is to be controlled by bixalomer.
*For those who meet the Case 2 in the inclusion criteria
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
20 years-old <=
Age-upper limit

Not applicable
Gender Male and Female
Key inclusion criteria 1) Patients with chronic renal failure under hemodialysis who fall into i) or ii):
i)
Patients currently on sevelamer hydrochloride who want to switch to bixalomer for some reasons; for instance,
they are reluctant to take sevelamer due to its gastrointestinal side-affects; or, they cannot increase its dose sufficiently because of those reactions (Case 1)
ii)
Patients who discontinued sevelamer in the past because of its side-effects such as gastrointestinal dysfunction, and want to change their medication to bixalomer while currently taking another agent for hyperphosphatemia (Case 2)
2) Aged 20 or older
3) Patients able to consent to their participation in writing by themselves
Key exclusion criteria 1) Patients with an intestinal blockage
2) Patients suffering from severe astriction or diarrhea continuously
3) Patients who have experienced gastrointestinal tract ulcer or a surgery in the abdomen
4) Patients with liver dysfunction (whose AST or ALT value is more than twice, or T-Bil value is more than 1.5 times higher than the standard level of the hospital they visit), or patients with a severe hepatic disorder such as cirrhosis
5) Patients who are expecting a child, lactating or suspected of pregnancy, or patients who want to be pregnant during their participation in this study
6) Patients considered as ineligible for this study by the investigator for another reason
Target sample size 50

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Satoshi Kurihara
Organization Keijukai Healthcare Corporation,
Saitama Tsukinomori Clinic
Division name General Hospital Director
Zip code
Address 366-1 Mashinaga, Iwatsuki-ku, Saitama-shi, Saitama, Japan
TEL 048-792-1811
Email

Public contact
Name of contact person
1st name
Middle name
Last name
Organization Keijukai Healthcare Corporation,Saitama Tsukinomori Clinic
Division name General Hospital Director
Zip code
Address
TEL 048-792-1811
Homepage URL
Email

Sponsor
Institute Keijukai Healthcare Corporation,Saitama Tsukinomori Clinic
Institute
Department

Funding Source
Organization Astellas Pharma Inc.
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization Japan

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 さいたまつきの森クリニック(埼玉県)、春日部内科クリニック(埼玉県)、岩槻南病院 (埼玉県)、武蔵嵐山病院(埼玉県)、埼友クリニック(埼玉県)

Other administrative information
Date of disclosure of the study information
2013 Year 05 Month 09 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 12 Month 25 Day
Date of IRB
Anticipated trial start date
2013 Year 04 Month 10 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
2013 Year 05 Month 08 Day
Last modified on
2014 Year 06 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012478

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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