The purpose of this randomized, controlled pilot study is to evaluate the performance of this novel Anemia Controller (vis-à-vis standard of care) for anemia management in hemodialysis patients. Since the Anemia Controller is designed to bring patients to a pre-defined Hgb target level and keep them there, the target population for this study are patients whose Hgb levels are currently not well-controlled (rather than patients who are already relatively stable within the Hgb target range under a standard anemia management algorithm). Specifically, therefore, the target population for this clinical study are chronic hemodialysis patients who are exhibiting Hgb cycling.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
60
Model Predictive Controller software (called "Anemia Controller") that utilizes our physiology-based erythropoiesis model to provide ESA dosing recommendations in order to guide a patient's Hgb level towards a predefined target value.
RRI
New York, New York, United States
RECRUITINGPercentage of time spent within a Hgb target range
The primary objective of the study is to compare the percentage of time patients will spend within the Hgb target range of 10-11 g/dL when treated with the Anemia Model Predictive Controller (intervention group) vs. when treated with the Standard of Care Algorithm (control group)
Time frame: 26 weeks
ESA accumulated dose (mcg/Kg)
Compare ESA accumulated dose (mcg/Kg) between the intervention and control groups (crude as well as adjusted for attained Hgb levels)
Time frame: 26 weeks
Statistical measures of Hgb variability
Compare the intervention group to the control group with respect to statistical measures of Hgb variability, including gradual fluctuations in pre-dialysis Hgb levels (g/dL) with a cyclic pattern (a cycle duration from 6 to 21 weeks, and an amplitude of at least 1.5 g/dL.)
Time frame: 26 weeks
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