Comparing study of the efficiency and safety in actual use of two kinds of long-acting ESA for renal anemia in hemodialysis patients

Comparing study of the efficiency and safety in actual use of two kinds of long-acting ESA for renal anemia in hemodialysis patients - Evaluation analysis for the treatment of renal anemia : two new long-acting ESAs randomised comerison trial:EARNEST STUDY

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000010704

Enrollment

150

Registered

2013-05-13

Start date

2013-04-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Renal anemia in hemodialysis patients

Interventions

darbepoetin alfa epoetin beta pegol

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Proportion of subjects on maintained with a target Hb level after switching from rHuEPO to two kinds of long-acting ESA	—

Secondary

Measure	Time frame
dose of two long-acting ESAs,iron metabolism,inflammatory markers,rate from rHuEPO to long-acting ESAs,hemoglobin variability and complications	—

Countries

Japan

Contacts

Public ContactHironobu Inoue

Saiseikai Kumamoto Hospital kidney and urology center

hironobu-inoue@saiseikaikumamoto.jp096-351-8000

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026