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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007839
Receipt No. 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

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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
Email 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
Email matuhiko@z3.keio.jp

Sponsor
Institute Apheresis and Dialysis Center
Keio University, School of Medicine
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009240

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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