UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000008073 |
|---|---|
| Receipt number | 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 20:37:24 |
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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
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
ishijin@clin.medic.mie-u.ac.jp
Sponsor or person
Institute
Blood Purification Center, Mie University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000009496
