Study of Erythropoietin (EPO) Administration Schedule

JW Pharmaceutical

Status and phase

Completed

Phase 4

Conditions

Chronic Renal Failure

Anaemia

Treatments

Drug: recomon (Epoetin Beta)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01111630

CWP_RCM_R01

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

All

Ages

18 to 80 years old

Volunteers

No 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.