Efficacy of Epoetin Alfa Deep Tank in Treatment of Anemia in Patients With Chronic Kidney Disease Receiving Hemodialysis

Study Overview
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Brief Summary
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The purpose of this study is to evaluate whether the efficacy of Epoetin alfa DT is equivalent to that of Epoetin alfa RB for the treatment of anemia in patients with CKD receiving hemodialysis

Official Title
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A Randomized, Double-Blind, Equivalence Study of the Efficacy of Epoetin Alfa Manufactured by Deep Tank Bioreactor Technology and Epoetin Alfa Manufactured by Roller-Bottle Technology for the Treatment of Anemia in Patients With Chronic Kidney Disease (CKD) Receiving Hemodialysis

Conditions
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Nephrology

Intervention / Treatment
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* Drug: Epoetin alfa RB
* Drug: Epoetin alfa DT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: - Diagnosis of CKD and receiving hemodialysis for greater than or equal to 3 months before randomization - Mean HB level between 10 and 13 g/dL (inclusive) (mean of 2 values drawn at least 3 days apart during the screening period) - Currently receiving a stable dose of Epoetin alfa RB (i.e., EPOGEN® or PROCRIT®) for at least 6 weeks prior to randomization. Stable is defined as: less than or equal to 25% change in dose over 6 weeks, same frequency and route of administration with no more than 1 missed or withheld dose during each of the two three-week periods before randomization Exclusion Criteria: - Uncontrolled hypertension, defined as a pre-dialysis systolic BP greater than 180 and/or diastolic BP of greater than 110 during the screening period - Known history of severe hyperparathyroidism (PTH Greater than 1500 pg/ml within 3 months prior to enrollment) - Currently receiving immunosuppressive therapy

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: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Epoetin alfa RB<br> | Drug: Epoetin alfa RB<br>* Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.<br>|
| Experimental: Epoetin alfa DT<br> | Drug: Epoetin alfa DT<br>* Receive drug at same frequency and dose as at the time of randomization Change dose by+/- 25% in order to maintain Hb between 10.0 - 13.0 g/dL and within -1.0 to +1.5 g/dL of the subject's baseline Hb.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of weekly dose at the evaluation period to the weekly dose at baseline |  | Entire Study | 
| Change in Heloglobin level between the screening period and the evaluation period |  | Entire Study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Hb at each measurement timepoint |  | Entire Study | 
| Maintaining Hemoglobin within range at each measurement timepoint |  | Entire Study | 
| Average Epoetin alfa dose over evaluation period |  | evaluation period (weeks 21 - 28) | 
| Change from baseline dose at each measurement timepoint |  | entire study | 
| Epoetin alfa seroreactivity |  | entire study | 
| Subject incidence, nature and severity of adverse events |  | entire study | 
| Hemoglobin variability |  | entire study | 
| changes from baseline laboraotry and vital sign parameters |  | entire study | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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anemia, chronic kidney disease, CKD, hemodialysis, epoetin, Epogen®