UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000011150 |
|---|---|
| Receipt number | R000013052 |
| Scientific Title | Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized controlled analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis |
| Date of disclosure of the study information | 2013/07/09 |
| Last modified on | 2015/07/09 11:15:21 |
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Basic information
Public title
Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized controlled analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis
Acronym
Switching from sevelamer hydrochloride to bixalomer in hemodialysis patients
Scientific Title
Switching hemodialysis patients from sevelamer hydrochloride to bixalomer: a single-center, non-randomized controlled analysis of efficacy and effects on gastrointestinal symptoms and metabolic acidosis
Scientific Title:Acronym
Switching from sevelamer hydrochloride to bixalomer in hemodialysis patients
Region
| Japan |
Condition
Condition
End-stage renal failure, Hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Safety and effectiveness of switching maintenance dialysis patients from sevelamer hydrochloride to bixalomer
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
Improvement of gastrointestinal symptoms 12 weeks after the switch
Key secondary outcomes
Improvement in metabolic acidosis, changes in blood biochemistry, and safety 12 weeks after the switch
Base
Study type
Study design
Basic design
Parallel
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention group:Patients were switched from sevelamer hydrochloride to bixalomer (1:1 dose)
Interventions/Control_2
Control gtoup: Patients without sevelamer hydrochloride agent were enrolled as a control group
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
| 80 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Patients were included if they (1) were aged 20 to 80 years, were stable on hemodialysis sessions started at least 1 year before study entry; (2) provided written informed consent to participation; (3) had not changed their
9
regimen of phosphate-lowering drugs, cinacalcet hydrochloride (if used), and other medications that could affect serum phosphorus levels for at least 28 days before study entry; (4) had not changed their dialysis regimens for at least 28 days before study entry; (5) had not changed other factors, including dietary therapy and concomitant drugs, during the study period; and (6) were in good general health, with an Eastern Cooperative Oncology Group Performance Status (ECOG-PS) grade of 0 or 1
Key exclusion criteria
Patients were excluded if they (1) had a history of gastrointestinal surgery (excluding polypectomy), dysphagia, ileus, gastrointestinal bleeding, severe persistent constipation or diarrhea, or had received parathyroid intervention within 3 months of study entry, (2) showed unstable control of serum phosphorus and calcium levels; or (3) were in poor general health, or had a major concomitant malignant disease or another medical condition likely to result in death within 6 months of study entry.
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University Graduate School of Medicine
Division name
Urology
Zip code
Address
5 Zaifu-chou
TEL
+81-172-39-5091
shingorilla2@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Shingo Hatakeyama |
Organization
Hirosaki University, School of Medicine
Division name
Urology
Zip code
Address
5 Zaifu-chou
TEL
+81-172-39-5091
Homepage URL
shingorilla2@gmail.com
Sponsor or person
Institute
OYOKYO Kidney Research Institute
Institute
Department
Personal name
Funding Source
Organization
OYOKYO Kidney Research Institute
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 07 | Month | 09 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
http://www.biomedcentral.com/1471-2369/14/222
Number of participants that the trial has enrolled
Results
Before switching, symptoms of epigastric fullness were significantly worse in the switch than in the control group. Twelve weeks after the switch, reflux, epigastric fullness, and constipation had improved significantly in the switch group. Other factors, including stomach ache, diarrhea, and form of stool, did not change significantly. Blood gas analysis showed that metabolic acidosis was significantly improved by switching. Four patients (14%) experienced grade 1 adverse events, all of which improved immediately after stopping BXL. Major adverse events were diarrhea and abdominal discomfort.
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 | 06 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2012 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
| 2013 | Year | 04 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 05 | Month | 01 | Day |
Date analysis concluded
| 2013 | Year | 08 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 07 | Month | 09 | Day |
Last modified on
| 2015 | Year | 07 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013052
