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

JW Pharmaceutical1 site in 1 country60 target enrollmentOctober 2009

ConditionsChronic Renal Failure Anaemia

Interventionsrecomon (Epoetin Beta)

Drugsrecomon (Epoetin Beta)

Overview

Phase: Phase 4
Intervention: recomon (Epoetin Beta)
Conditions: Chronic Renal Failure
Sponsor: JW Pharmaceutical
Enrollment: 60
Locations: 1
Primary Endpoint: The hemoglobin variability between once & three times weekly administration
Status: Completed
Last Updated: 11 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

October 2009

End Date

January 2014

Last Updated

11 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

JW Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients aged between 18 and
•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.

Arms & Interventions

once weekly

Intervention: recomon (Epoetin Beta)

three times weekly

Intervention: recomon (Epoetin Beta)

Outcomes

Primary Outcomes

The hemoglobin variability between once & three times weekly administration

Time Frame: 24 weeks

Secondary Outcomes

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