The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Study Overview
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Brief Summary
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Hypothesis: Routine clinical tests with feedback control based Epogen(Epo)/Venofer(Iron) protocol will improve Hemoglobin (Hgb) stability and increase the time that patients remain in target Objectives: Decreased variability of Hgb Increase the % of patients in target range c Increase in time that Hgb remains target range

Detailed Description
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Study Design One dialysis unit shift comprising up to 200 patients. Study participation will last for 12 months broken into 3 phases as described below. Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP. The individual AMP will be utilized weekly during the 9 months of Phase 2. The 3 objectives will be evaluated and updated weekly, Baseline to Year 1. All Epo dosing recommendations must be reviewed by the treating physician who can either accept or modify doses at his/her discretion based on clinical event that are not includes in the transmitted data such as bleeding, infection, and hospitalization.

Official Title
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The Effect of Epogen and Venofer Dosing Management on Hemoglobin Stability

Conditions
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Anemia, End Stage Renal Disease

Intervention / Treatment
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* Other: Individualized Anemia Mangement Protocol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 18 years old or older Receiving hemodialysis in an out-patient dialysis unit Exclusion Criteria: Not receiving EPOGEN as part of their standard medical care Patient refusal

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Individualized Anemia Mangement Protocol<br>Single arm study, therefore all patients will participate in the following: Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP . | Other: Individualized Anemia Mangement Protocol<br>* Phase 1 (1-3 months): Develop individualized patient models and Anemia Management Protocols (AMP) while patients are receiving standard medical care. Phase 2 (9 months): Individualized AMP study period. Phase 3 (9 months): Follow up period: return to standard-care AMP .<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraindividual Hemoglobin (Hgb) variability | Change in average intraindividual Hgb variability between control period and treatment periods. | Evaluated and updated weekly for 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Average hemoglobin levels | Change in average Hgb levels between control treatment periods, and change in interindividual Hgb variability between control treatment periods. | Evaluated and updated weekly for 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Anemia, End Stage Renal Disease