UMIN-CTR Clinical Trial

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
Email	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
Email	hironobu-inoue@saiseikaikumamoto.jp

Sponsor
Institute	Saiseikai Kumamoto Hospital
Institute
Department

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
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

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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000012457