Study of Erythropoietin (EPO) Administration Schedule

• Status: Completed
• Trial end date: 2014-01-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: JW Pharmaceutical
• Treatments: Epoetin Alfa

Criteria

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.