UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000009792 |
|---|---|
| Receipt number | R000011470 |
| Scientific Title | Comparision of bixalomer (Kiklin) dose timing as phosphate binder and impact in HD patients |
| Date of disclosure of the study information | 2013/04/01 |
| Last modified on | 2014/02/17 10:06:59 |
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Basic information
Public title
Comparision of bixalomer (Kiklin) dose timing as phosphate binder and impact in HD patients
Acronym
Skip-study 2
Scientific Title
Comparision of bixalomer (Kiklin) dose timing as phosphate binder and impact in HD patients
Scientific Title:Acronym
Skip-study 2
Region
| Japan |
Condition
Condition
Hemodialysis patients with hyperphosphatemia
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Superiority of taking bixalomer (Kiklin) after meals on phosphate binding activity and adverse effects in HD patients
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Level of serum phosphate
Key secondary outcomes
Evaluation of efficacy
*Blood gas concentrations
*Abdominal symptoms evaluation
*Drug remedy time estimation
*Adverse events
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Historical
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 patients managed hyperphosphatemia with taking bixalomer just before each meal will take them after each meal.
The dose of bixalomer is fixed during the observation. The level of serum phosphate, the prevalence and severity of abdominal symptoms caused by bixalomer and the prevalence of adverse effects will be examined during 3 months
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 managed with bixalomer.
2.30 patients with agreement for exchange of midication mode from taking bixalomer before meal to after meal.
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
ients 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 | Chieko Hamada |
Organization
Juntendo University Faculty of Medicine
Division name
Department of Internal Medicine, Division of Nephrology
Zip code
Address
3-1-3 Hongo, Bunkyo-ku,Tokyo, 113-8421,Japan
TEL
03-3813-3111
chieko@juntendo.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
3-1-3 Hongo, Bunkyo-ku,Tokyo, 113-8421,Japan
TEL
03-3813-1183
Homepage URL
chieko@juntendo.ac.jp
Sponsor or person
Institute
Juntendo University Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Internal Medicine, Division of Nephrology,Juntendo University faculty of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
順天堂大学医学部附属順天堂医院（東京都）
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 04 | 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
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 31 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2014 | Year | 07 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 01 | Month | 16 | 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=R000011470
