UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007839 |
|---|---|
| Receipt number | R000009240 |
| Scientific Title | The examination of appropriate switching dose of epoetin beta pegol from short-acting epoetin in the treatment of anemia in the patients on chronic hemodialysis. |
| Date of disclosure of the study information | 2012/05/01 |
| Last modified on | 2017/04/12 14:14:30 |
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Basic information
Public title
The examination of appropriate switching dose of epoetin beta pegol from short-acting epoetin in the treatment of anemia in the patients on chronic hemodialysis.
Acronym
The examination of switching dose of epoetin beta pegol
Scientific Title
The examination of appropriate switching dose of epoetin beta pegol from short-acting epoetin in the treatment of anemia in the patients on chronic hemodialysis.
Scientific Title:Acronym
The examination of switching dose of epoetin beta pegol
Region
| Japan |
Condition
Condition
Patients on chronic hemodialysis
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In most patients on chronic hemodialysis, anemia is treated by short-acting epoetin (epoetin alpha, epoetin beta). We are going to examine whether hemoglobin concentration is maintained when short-acting epoetin is appropriately switched to epoetin beta pegol depending a dose of previous short-acting epoetin in the patients whose dose of short-acting epoetin and appropriate hemoglobin level, which is defined by the guideline of Japanese Society of Dialysis and Transplantation, are maintained for the previous three months.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Hemoglobin concentration, dose of epoetin beta pegol
Key secondary outcomes
Base
Study type
Interventional
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
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pre-switching dose of epoetin is less than or equal to 4500 units/week; switch to 75 microgram once a month
Interventions/Control_2
Pre-switching dose of epoetin 4500< and less than or equal to 9000 units/week; switch to 150 microgram once a month
Interventions/Control_3
Pre-switching dose of epoetin > 9000 units/week; switch to 225 microgram once a month
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1 Patients who maintained target hemoglobin level, which is defined by the guideline of he Japanese Society of Dialysis and Transplantation, for more than three consecutive months
2 Patients who are given short-acting epoetin for longer than three months and their doses were not changed for three consecutive months before switching
3 The patients who are 20 years old or older than 20 years old, and 75 years old or younger than 75years old
Key exclusion criteria
Patients with severe heart failure
Patients who can not be obtained written informed consent
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Matsuhiko Hayashi |
Organization
Keio University, School of Medicine
Division name
Apheresis and Dialysis Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3908
matuhiko@z3.keio.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Matsuhiko Hayashi |
Organization
Keio University, School of Medicine
Division name
Apheresis and Dialysis Center
Zip code
Address
35 Shinanomachi, Shinjuku-ku, Tokyo
TEL
03-5363-3908
Homepage URL
matuhiko@z3.keio.jp
Sponsor or person
Institute
Apheresis and Dialysis Center
Keio University, School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Keio University, School 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
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
| 2012 | Year | 05 | 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 | 04 | Month | 09 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2015 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
| 2016 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2016 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2016 | Year | 06 | Month | 30 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 04 | Month | 26 | Day |
Last modified on
| 2017 | Year | 04 | Month | 12 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009240
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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