Study of Erythropoietin (EPO) Administration Schedule

NCT ID: NCT01111630

Last Updated: 2014-05-14

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-10-31
• Study Completion Date: 2014-01-31

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.

Conditions

Chronic Renal Failure; Anaemia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

once weekly

Group Type: EXPERIMENTAL

recomon (Epoetin Beta)

Intervention Type: DRUG

administer once weekly

three times weekly

Group Type: ACTIVE_COMPARATOR

recomon (Epoetin Beta)

Intervention Type: DRUG

administer three times weekly

Interventions

recomon (Epoetin Beta)

administer once weekly

Intervention Type: DRUG

recomon (Epoetin Beta)

administer three times weekly

Intervention Type: DRUG

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

JW Pharmaceutical

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

SugKyun Shin, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

National Health Insurance Service Ilsan Hospital

Locations

NHIC Ilsan Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

CWP_RCM_R01

Identifier Type: -

Identifier Source: org_study_id