Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

Study Overview
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Brief Summary
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The purpose of this research study was to determine if the activity of erythropoietin (r-HuEPO) is time dependent when given to chronic renal failure patients at three different times of day.

Detailed Description
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This phase-II crossover study was designed to test if the activity of erythropoietin is time dependent. Patients with chronic renal failure on hemodialysis requiring r-HuEPO to maintain adequate levels of hematocrit are eligible for the study. Patients were administered r-HuEPO subcutaneously three times per week, 50 U/kg, rounded to the nearest 2000 units. r-HuEPO will be administered until the hematocrit rises from the baseline level of 20-24% to the target level of 30-34%. This will be repeated three times, each at different times of day, either 0800, 1500 or 2200 hrs and the order of these will be randomly determined. Each patient will complete all three of the phases.

Official Title
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Erythropoietin Therapy in Patients With Chronic Renal Failure: A Study of Time Dependent Activity

Conditions
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Hemodialysis, Chronic Renal Failure, Anemia

Intervention / Treatment
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* Drug: r-HuEPO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Chronic renal failure patients requiring hemodialysis and requiring r-HuEPO to maintain adequate hematocrit levels Serum ferritin level > 200 micrograms/L and transferrin saturation > 15% Serum erythropoietin level less than 500 mu/ml (when off r-HuEPO) Prior therapy with r-HuEPO An adequate program of dialysis established Informed consent signed Exclusion Criteria: Adocumented cause of anemia other than chronic renal disease Symptoms of unstable coronary artery disease Poorly controled hypertension Known seizure disorder Other active inflammatory or infective disorders Other disorders that may diminish the response of the bone marrow to r-HuEPO

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Active Comparator: 0800<br>r-HuEPO administered at 0800 hrs | Drug: r-HuEPO<br>* r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.<br>|
| Active Comparator: 1500<br>r-HuEPO administered at 1500 hrs | Drug: r-HuEPO<br>* r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.<br>|
| Active Comparator: 2200<br>r-HuEPO administered at 2200 hrs | Drug: r-HuEPO<br>* r-HuEPO 50 U/kg s.c. three times per week. The dose is rounded to the nearest 2000 unites.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time for hematocrit to rise |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, erythropoietin