Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients

Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients: A Pilot Study

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.

Inclusion Criteria:

• Age ≥18 years
• Ability to give written informed consent to the study
• End-stage renal disease treated with thrice-weekly hemodialysis for at least 180 days preceding enrollment
• Receiving intradialytic Crit-Line® monitoring, with available Crit-Line® data going back at least 180 days from the date of enrollment
• Laboratory Hgb data going back at least 180 days from the date of enrollment
• On average, Hgb values available from at least 2 treatments per week (from either source, Crit-Line® or laboratory) during the past 180 days preceding enrollment
• Renal anemia treated with intravenous Mircera®, with at least 2 Mircera® dose administrations during the 150 days preceding enrollment
• On an active Mircera® anemia management algorithm order during the 180 days preceding enrollment
• Exclusively on Mircera® (no other ESAs) during the 180 days preceding enrollment
• Pattern of Hgb cycling as defined above during the 180 days preceding enrollment

Exclusion Criteria:

• Having received the maximum Mircera® dose (225 µg every other week) consistently throughout the 90 days preceding enrollment
• Hospitalization for more than 10 days during the 30 days preceding enrollment
• Severe iron deficiency (TSAT <20%, ferritin <100 ng/mL) in the most recent routine blood work prior to enrollment
• Any known cause of ESA resistance other than iron deficiency and inflammatory states (e.g. hematologic malignancies, hypersplenism, antibody mediated pure red cell aplasia)
• Simultaneous participation in another clinical study that may impact anemia management or the outcomes of this trial
• Inability to communicate in English or Spanish