Study of Erythropoietin (EPO) Administration Schedule

Phase 4

Completed

• Conditions: Chronic Renal Failure; Anaemia
• Interventions: Drug: recomon (Epoetin Beta)

• Registration Number: NCT01111630
• Lead Sponsor: JW Pharmaceutical

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-10
• Study First Submitted: 2010-04-25
• Study First Submitted QC: 2010-04-26
• Study First Posted: 2010-04-27
• Primary Completion: 2013-10
• Study Completion: 2014-01
• Status Verified: 2014-05
• Last Update Submitted: 2014-05-12
• Last Update Posted: 2014-05-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
three times weekly	recomon (Epoetin Beta)	-
once weekly	recomon (Epoetin Beta)	-

Primary Outcome Measures

Name	Time	Method
The hemoglobin variability between once & three times weekly administration	24 weeks

Secondary Outcome Measures

Name	Time	Method
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 between once & three times weekly administration	24 weeks
Mean value of Hb and Hct during dose fix period	24 weeks

Trial Locations

Locations (1)

NHIC Ilsan Hospital; 🇰🇷 Seoul, Korea, Republic of