Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
NA
62 participants
INTERVENTIONAL
2011-04-30
2012-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Control
ESA Dose Adjustment per standard Anemia Management Protocol
ESA Dose Adjustment per standard Anemia Management Protocol
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
Treatment
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm
Interventions
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ESA Dose Adjustment per standard Anemia Management Protocol
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. receiving dialysis treatment,
3. receiving or expected to receive ESA treatment,
4. adequacy of dialysis Kt/V \>= 1.2,
5. adequate iron stores (Ferritin \> 200 ng/mL, TSat \> 20%).
Exclusion Criteria
2. frequent uncontrolled blood loss,
3. frequent dialyzer clotting,
4. frequent access related problems,
5. active infections,
6. severe cardiac disability,
7. coronary bypass within three months prior to the study
8. documented resistance to ESA
9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Louisville
OTHER
Responsible Party
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Adam Edward Gaweda
Associate Professor
Principal Investigators
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Adam E Gaweda, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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University of Louisville Kidney Disease Program
Louisville, Kentucky, United States
Countries
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Other Identifiers
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