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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000008073
Receipt No. R000009496
Scientific Title 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
Date of disclosure of the study information 2012/06/01
Last modified on 2018/06/06

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Basic information
Public title 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
Acronym Treatment of anemia in hemodialysis patients: CERA vs NESP
Scientific Title 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
Scientific Title:Acronym 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
1st name
Middle name
Last name Eiji Ishikawa
Organization Mie University Hospital
Division name Blood Purification Center
Zip code
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
1st name
Middle name
Last name Eiji Ishikawa
Organization Mie University Hospital
Division name Blood Purification Center
Zip code
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)

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 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

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 05 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000009496

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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