Study of Erythropoietin (EPO) Administration Schedule

Compare the Hemoglobin and Hematocrit Variability Between Once & Three Times Weekly Erythropoietin Therapy for the Anemia in Patients With Maintenance Dialysis

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01111630

Enrollment

Registered

2010-04-27

Start date

2009-10-31

Completion date

2014-01-31

Last updated

2014-05-14

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

Conditions

Anaemia, Chronic Renal Failure

Keywords

chronic renal failure, Anaemia

Brief summary

The purpose of this study is to compare the hemoglobin and hematocrit variability between once and three times weekly erythropoietin therapy for the anemia in patients with maintenance dialysis.

Interventions

DRUGrecomon (Epoetin Beta)

administer once weekly

Study design

Allocation

RANDOMIZED

Intervention model

CROSSOVER

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* Patients aged between 18 and 80. * Dialysis for at least 3 months. * Epoetin treatment for the last 3 months. * Baseline hemoglobin (Hb) value of \>= 9.0 g/dL and \< 13.0 g/dL. * Baseline mean weekly epoetin maintenance dose ≤ 12,000 IU * Patients who agree to participate in this study in writing.

Exclusion criteria

* Hemoglobinopathies, i.e. sickle cell disease, thalassemia of all types. * Hemolysis as defined * Gastrointestinal bleeding necessitating treatment (medication, transfusion) within the last 3 months. * Patients with uncontrolled hypertension. * Acute infection of unstable systemic inflammatory disease. * Current malignant disease. * High likelihood of early withdrawal or interruption of the study (e.g. severe diseases within the last 3 months, such as myocardial infarction, unstable angina, stroke, deep venous thrombosis). * Life expectancy below 12 months. * Planned elective surgery during the study period. * Blood transfusions within the last 3 months. * Pregnancy and lactation. * Other conditions regarded as unsuitability by investigator.

Design outcomes

Primary

Measure	Time frame
The hemoglobin variability between once & three times weekly administration	24 weeks

Secondary

Measure	Time frame
Mean value of Hb and Hct between once & three times weekly administration	24 weeks
Drop out rate during dose fix period	24 weeks
The hematocrit variability between once & three times weekly administration	24 weeks
Variability of Hb and Hct during dose fix period	24weeks
Weekly oetin-beta maintenance dose between once & three times weekly administration	24 weeks
Mean value of Hb and Hct during dose fix period	24 weeks

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026