UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Methoxy Polyethylene Glycol-Epoetin Beta Once A Month Versus Darbepoetin Alfa Once A Week for Treatment of Anemia in Hemodialysis Patients: A Randomized, Multicenter, Open-label Trial
Title of the study (Brief title)	Treatment of anemia in hemodialysis patients: CERA vs NESP
Region	Japan

Condition
Condition	Hemodialysis patients with renal anemia
Classification by specialty	Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	The purpose of the present study is to verify whether Continuous Erythropoietin Receptor Activator (CERA) once a month can maintain the hemoglobin level as much as Novel Erythropoiesis Stimulating Protein (NESP) once a week in hemodialysis patients with anemia.
Basic objectives2	Bio-equivalence
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Frequency that hemoglobin level becomes less than 10g/dl for six months evaluation period (12 times of observation).
Key secondary outcomes	Frequency that hemoglobin level becomes out of target range (10-12g/dl) for six months evaluation period . Frequency that hemoglobin level becomes over 12g/dl for six months evaluation period. Average value and coefficient of variance of hemoglobin for six months evaluation period. Frequency that hemoglobin level becomes less than 10g/dl for 12 months study period. Frequency that hemoglobin level becomes out of target range (10-12g/dl) for 12 months study period . Complications (death, new onset of cardiovasculr disease, and vascular access failure)

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is considered as a block.
Blocking	YES
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Continuous Erythropoietin Receptor Activator (CERA) once a month
Interventions/Control_2	Novel Erythropoiesis Stimulating Protein (NESP) once a week
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	Not applicable
Gender	Male and Female
Key inclusion criteria	Hemodialysis patients treated with NESP once a week Keep hemoglobin level between 10 to 12g/dl for 3 months before entry Patient who is obtaining written agreement by free will of patient himself after enough informed consent
Key exclusion criteria	Hemodialysis vintage less than 6 months Inpatient Patient who received transfusion within six months Anemic patient who has another cause of renal anemia like hematological or gastrointestinal diseases Patient who has poor prognostic malignancy Patient who can not agree with the study Patient who was judged inadequate case for the study by doctor
Target sample size	110

Research contact person
Name of lead principal investigator	Eiji Ishikawa
Organization	Mie University Hospital
Division name	Blood Purification Center
Address	2-174 Edobashi Tsu-city Mie, Japan
TEL	059-231-5403
Email	ishijin@clin.medic.mie-u.ac.jp

Public contact
Name of contact person	Eiji Ishikawa
Organization	Mie University Hospital
Division name	Blood Purification Center
Address	2-174 Edobashi Tsu-city Mie, Japan
TEL	059-231-5403
Homepage URL
Email	ishijin@clin.medic.mie-u.ac.jp

Sponsor
Institute	Blood Purification Center, Mie University Hospital
Institute
Department

Funding Source
Organization	The Kindney Foundation, Japan
Organization
Division
Category of Funding Organization	Non profit foundation
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	桑名東医療センター（三重県）、四日市社会保険病院（三重県）、村瀬病院（三重県）、鈴鹿回生病院（三重県）、亀山医療センター（三重県）、武内病院（三重県）、遠山病院（三重県）、上野総合市民病院（三重県）、伊勢赤十字病院（三重県）、ハートクリニック福井（三重県）

Other administrative information
Date of disclosure of the study information	2012 Year 06 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 05 Month 31 Day
Anticipated trial start date	2012 Year 06 Month 01 Day
Last follow-up date	2014 Year 07 Month 31 Day
Date of closure to data entry	2014 Year 12 Month 31 Day
Date trial data considered complete	2015 Year 01 Month 31 Day
Date analysis concluded	2015 Year 03 Month 31 Day

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

Management information
Registered date	2012 Year 05 Month 31 Day
Last modified on	2018 Year 06 Month 06 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000009496