Abstract: PUB080
Therapy Software for Personalized Anemia Management in Hemodialysis Patients: Description of the Population in a Randomized Controlled Trial
Session Information
Category: Anemia and Iron Metabolism
- 200 Anemia and Iron Metabolism
Authors
- Rivera Fuentes, Lemuel, Renal Research Institute, New York, New York, United States
- Joerg, David J., Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Fuertinger, Doris H., Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany
- Wang, Lin-Chun, Renal Research Institute, New York, New York, United States
- Patel, Amrish U., Renal Research Institute, New York, New York, United States
- Ye, Xiaoling, Renal Research Institute, New York, New York, United States
- Thijssen, Stephan, Renal Research Institute, New York, New York, United States
- Kotanko, Peter, Renal Research Institute, New York, New York, United States
Background
Anemia is a common complication in patients on hemodialysis (HD). The use of erythropoiesis-stimulating agents (ESA) has become standard-of-care (SOC). The non-linear relationship between ESA administration and hemoglobin (Hgb) response is one of the biggest challenges in anemia management. Therefore, we devised a novel software that individualizes ESA-dose prescription based on mathematical modeling of anemia. We present the design of our randomized controlled trial (RCT) and a brief description of the population enrolled.
Methods
We conducted an RCT in subjects on HD who were randomized 1:1 to be managed by our personalized ESA-dose recommendation tool (intervention) or continue to be on SOC treatment (control). For 26 weeks the intervention group received biweekly individualized ESA-recommendations generated by our software to target an Hgb of 10-11 g/dL. These recommendations were provided to an anemia manager who evaluated the subject’s clinical status before ESA administration. The software was updated biweekly with the subjects’ most recent clinical parameters.
Results
Ninety-six subjects were enrolled, 82 were randomized and completed the study (61 [50.2-70.7] years, 58.1% male, 51.2% black, Hgb of 10.5 ± 0.4 g/dL, Ferritin 812 [489.3-1117.5] ng/mL) (Table 1). Forty subjects were randomized to the intervention arm and 42 to the control. When comparing general data (demographics, comorbidities, etc.) there was no statistical significance between the two arms (Table 1).
Conclusion
We successfully conducted a clinical RCT to test our therapy software for personalized anemia management in HD patients. The population enrolled and randomized was balanced between the 2 arms.