UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	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.
Title of the study (Brief title)	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	Matsuhiko Hayashi
Organization	Keio University, School of Medicine
Division name	Apheresis and Dialysis Center
Address	35 Shinanomachi, Shinjuku-ku, Tokyo
TEL	03-5363-3908
Email	matuhiko@z3.keio.jp

Public contact
Name of contact person	Matsuhiko Hayashi
Organization	Keio University, School of Medicine
Division name	Apheresis and Dialysis Center
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)

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 04 Month 09 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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