Effects of Individualized ESA Dosing Recommendations From Anemia Therapy Assistance Software

Maintaining stable hemoglobin levels within a target range while on hemodialysis can be difficult. Therefore, anemia is common among patients receiving dialysis.

Doris H. Fuertinger, PhD, and colleagues hypothesized that individualized dosing of erythropoiesis-stimulating agents (ESAs) could help hemodialysis patients achieve hemoglobin targets.

The researchers conducted a multicenter, randomized, controlled pilot trial in this population comparing a physiology-based individualized anemia therapy assistance software and a standard population-based anemia treatment protocol. The results were published in the Clinical Journal of the American Society of Nephrology.

The study included 96 patients receiving hemodialysis and methoxy polyethylene glycol-epoetin beta. They were randomized 1:1 to either an intervention group with personalized ESA dose recommendations determined by the software or a standard-of-care group for 26 weeks.

The software utilized a physiology-based mathematical model and a model predictive controller designed to stabilize hemoglobin levels within a strict target range (10-11 g/dl). The primary outcome of the study was the percentage of hemoglobin measurements staying within the target range. Secondary outcomes included measures of hemoglobin variability and ESA utilization.

The intervention group demonstrated an improved median percentage of hemoglobin levels within the target range at 47% (IQR, 39-58), with a 10% point median difference between the two groups (95% CI, 3-16; P=.008). The odds ratio of staying within the target range in the standard-of-care group was 0.68 (95% CI, 0.51-0.92) compared to the intervention group.

Variability of hemoglobin levels declined in the intervention group. The percentage of patients with fluctuating hemoglobin levels was 45% in the intervention group compared to 82% in the standard-of-care group. The use of ESAs decreased by approximately 25% in the intervention group.

In conclusion, the study found that patients in the group receiving personalized ESA dosing recommendations from physiology-based anemia therapy assistance software demonstrated improvement in hemoglobin stability and ESA utilization.

Source: Clinical Journal of the American Society of Nephrology