Study of Erythropoietin (EPO) Administration Schedule

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Renal Failure, Anaemia

Intervention / Treatment
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* Drug: recomon (Epoetin Beta)
* Drug: recomon (Epoetin Beta)


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: once weekly<br> | Drug: recomon (Epoetin Beta)<br>* administer once weekly<br>|
| Active Comparator: three times weekly<br> | Drug: recomon (Epoetin Beta)<br>* administer three times weekly<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hemoglobin variability between once & three times weekly administration |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The hematocrit variability between once & three times weekly administration |  | 24 weeks | 
| Mean value of Hb and Hct between once & three times weekly administration |  | 24 weeks | 
| Drop out rate during dose fix period |  | 24 weeks | 
| Mean value of Hb and Hct during dose fix period |  | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic renal failure, Anaemia