UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000010704 |
|---|---|
| Receipt number | R000012457 |
| Scientific Title | Comparing study of the efficiency and safety in actual use of two kinds of long-acting ESA for renal anemia in hemodialysis patients |
| Date of disclosure of the study information | 2013/05/13 |
| Last modified on | 2019/10/16 15:51:13 |
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Basic information
Public title
Comparing study of the efficiency and safety in actual use of two kinds of long-acting ESA for renal anemia in hemodialysis patients
Acronym
Evaluation analysis for the treatment of renal anemia : two new long-acting
ESAs randomised comerison trial:EARNEST STUDY
Scientific Title
Comparing study of the efficiency and safety in actual use of two kinds of long-acting ESA for renal anemia in hemodialysis patients
Scientific Title:Acronym
Evaluation analysis for the treatment of renal anemia : two new long-acting
ESAs randomised comerison trial:EARNEST STUDY
Region
| Japan |
Condition
Condition
Renal anemia in hemodialysis patients
Classification by specialty
| Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The object is to evaluate the efficiency and safety in actual use of two kinds of long-acting ESA for renal anemia in hemodialysis patients.
Basic objectives2
Bio-equivalence
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Proportion of subjects on maintained with a target Hb level after switching from rHuEPO to two kinds of long-acting ESA
Key secondary outcomes
dose of two long-acting ESAs,iron metabolism,inflammatory markers,rate from rHuEPO to long-acting ESAs,hemoglobin variability and complications
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
darbepoetin alfa
Interventions/Control_2
epoetin beta pegol
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
Patients who are on hemodialysis for a prescribed period (at least 4 weeks) and receiving rHuEPO preparation for renal anemia for at least 3 months
Key exclusion criteria
Women who are pregnant, breastfeeding, or possibly pregnant
Patients who have myocardial infarction,pulmonary embolism or stroke
Hypersensitivity to epoetin beta pegol or darbepoetin alfa
Patients who have malignant tumor (including hematologic malignancy), severe infection, Hemolytic anemia, hemolytic anemia, or apparent hemorrhagic lesion
Patients whose AST or ALT level was 100 IU/L or higher in the latest examination before enrollment
Patients who are judged ineligible by the investigator/sub-investigator
Target sample size
150
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuaki Soejima |
Organization
Saiseikai Kumamoto Hospital
Division name
kidney and urology center
Zip code
Address
Chikami 5-3-1,Minami-ku, Kumamoto
TEL
096-351-8000
hironobu-inoue@saiseikaikumamoto.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hironobu Inoue |
Organization
Saiseikai Kumamoto Hospital
Division name
kidney and urology center
Zip code
Address
Chikami 5-3-1,Minami-ku, Kumamoto
TEL
096-351-8000
Homepage URL
hironobu-inoue@saiseikaikumamoto.jp
Sponsor or person
Institute
Saiseikai Kumamoto Hospital
Institute
Department
Personal name
Funding Source
Organization
Saiseikai Kumamoto Hospital
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2013 | Year | 05 | Month | 13 | Day |
Related information
URL releasing protocol
Publication of results
Partially published
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
| 2013 | Year | 01 | Month | 23 | Day |
Date of IRB
| 2013 | Year | 04 | Month | 01 | Day |
Anticipated trial start date
| 2013 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 10 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
| 2016 | Year | 12 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2013 | Year | 05 | Month | 13 | Day |
Last modified on
| 2019 | Year | 10 | Month | 16 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012457
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
