UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010671 |
|---|---|
| Receipt number | 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 14:55:07 |
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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
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
Sponsor or person
Institute
Keijukai Healthcare Corporation,Saitama Tsukinomori Clinic
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012478
