Intelligent Control Approach to Anemia Management

Study Overview
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Brief Summary
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First clinical evaluation of Smart Anemia Manager algorithm.

Detailed Description
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The purpose of this single-center study is to test whether Smart Anemia Manager algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.

Official Title
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Intelligent Control Approach to Anemia Management (AIM 4)

Conditions
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End-Stage Renal Disease

Intervention / Treatment
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* Other: ESA Dose Adjustment per standard Anemia Management Protocol
* Other: ESA Dose Adjustment per Smart Anemia Manager Algorithm


Participation Criteria
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Eligibility Criteria
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Inclusion criteria: ages 18 to 80, receiving dialysis treatment, receiving or expected to receive ESA treatment, adequacy of dialysis Kt/V >= 1.2, adequate iron stores (Ferritin > 200 ng/mL, TSat > 20%). Exclusion criteria: life expectancy less than 12 months, frequent uncontrolled blood loss, frequent dialyzer clotting, frequent access related problems, active infections, severe cardiac disability, coronary bypass within three months prior to the study documented resistance to ESA bone marrow suppression due to HIV, leukemia, or pharmacologic agents.

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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br>ESA Dose Adjustment per standard Anemia Management Protocol | Other: ESA Dose Adjustment per standard Anemia Management Protocol<br>* Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility<br>* Other names: AMP;|
| Experimental: Treatment<br>ESA Dose Adjustment per Smart Anemia Manager Algorithm | Other: ESA Dose Adjustment per Smart Anemia Manager Algorithm<br>* Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by Smart Anemia Manager algorithm<br>* Other names: SAM;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Hb 10-12 g/dL | Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL. | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Hb < 10 g/dL | Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL. | 12 months | 
| Percent Hb > 12 g/dL | Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL. | 12 months | 
| Mean Hb | Mean Hemoglobin concentration over follow-up period | 12 months | 
| ESA Dose | Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV) | 12 months | 

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