
Patients receiving hemodialysis frequently develop anemia. Treating anemia with erythropoiesis-stimulating agents (ESAs) presents challenges and there is wide variation in hemoglobin outcomes in clinical practice. Doris H. Fuertinger and colleagues conducted a randomized controlled clinical trial (RCT) to examine the impact of an individualized anemia therapy tool on hemoglobin variability.
Results of the trial were reported during a poster session at the American Society of Nephrology Kidney Week 2023. The poster was titled Hemoglobin Variability in Hemodialysis Patients Improves Under Individualized Anemia Therapy.
Study participants were randomized 1:1 to be treated with an individualized ESA dose recommendation tool (intervention group) or an anemia management protocol (standard of care group) for 26 weeks. A total of 82 patients completed the study: 40 in the intervention group and 42 in the standard of care group.
A previously validated physiology-based model of anemia was used as a recommendation tool to estimate key patient-specific physiological characteristics such as red blood cell lifespan. The tool created a digital twin from recent clinical data. Individual ESA dose recommendations for methoxy polyethylene glycol-epoetin beta to target a hemoglobin window of 10 to 11 g/dL were generated based on the patient’s digital twin.
Over the study period, interpatient variation in mean hemoglobin levels were smaller in the intervention arm than in the standard of care arm (variance 0.15 vs 0.66 mg2/dL2; P<.001); the mean shifted to the center of the target range (10.5 to 10.8 g/dL). Over time, the distributions of mean monthly hemoglobin levels in the intervention arm progressively narrowed.
In addition, intrapatient hemoglobin variability (standard deviation around the mean hemoglobin levels) improved in the intervention arm compared with the standard of care arm (median 0.7 vs 0.9 g/dL; P=.001).
“The RCT results suggest that the individual ESA recommendations of the anemia therapy tool improves inter- and intrapatient hemoglobin variability, while also bringing mean hemoglobin levels into the desired target range.”
Source: Fuertinger DH, Joerg DJ, Ho K, et al. Hemoglobin variability in hemodialysis patients improves under individualized anemia therapy. TH-PO955. Abstract of a poster presented at the American Society of Nephrology Kidney Week 2023; November 2, 2023; Philadelphia, Pennsylvania. Funding was provided by Fresenius Medical Care.