Intelligent Control Approach to Anemia Management
Status
Completed
Conditions
End-Stage Renal Disease
Treatments
Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Other: ESA Dose Adjustment per standard Anemia Management Protocol
Study type
Interventional
Funder types
Other
NIH
Identifiers
Details and patient eligibility
About
First clinical evaluation of "Smart Anemia Manager" algorithm.
Full description
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.
Enrollment
62 patients
Sex
All
Ages
18+ years old
Volunteers
No Healthy Volunteers
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.
Trial design
Primary purpose
Other
Allocation
Randomized
Interventional model
Parallel Assignment
Masking
Double Blind
62 participants in 2 patient groups
Control
Active Comparator group
Description:
ESA Dose Adjustment per standard Anemia Management Protocol
Treatment:
Other: ESA Dose Adjustment per standard Anemia Management Protocol
Treatment
Experimental group
Description:
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Treatment:
Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Trial contacts and locations
1
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Data sourced from clinicaltrials.gov
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