Assessment of an Anemia Model Predictive Controller for Anemia Management in Hemodialysis Patients
- Conditions
- End Stage Renal DiseaseRenal AnemiaChronic Kidney Diseases
- Interventions
- Other: Anemia Controller
- Registration Number
- NCT04360902
- Lead Sponsor
- Renal Research Institute
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 60
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Group Anemia Controller For subjects randomized into the intervention group, our erythropoiesis model will be used to identify each subject's individual values for several physiological determinants of erythropoiesis based on his/her sex, body height and history of body weights, Hgb concentrations and Mircera® administrations over the preceding 150 to 180 days. For subjects in the intervention group, their current method of anemia management will be discontinued. From this point on, Mircera® dose recommendations will be generated by the Anemia Controller software based on our erythropoiesis model and each subject for the duration of their 26-week participation in this study. The Anemia Controller computes the Mircera® doses required to attain the target Hgb level of 10.5 g/dL. Controller-generated Mircera® recommendations will be communicated to the respective clinics' anemia managers on a standardized report.
- Primary Outcome Measures
Name Time Method Percentage of time spent within a Hgb target range 26 weeks 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)
- Secondary Outcome Measures
Name Time Method ESA accumulated dose (mcg/Kg) 26 weeks Compare ESA accumulated dose (mcg/Kg) between the intervention and control groups (crude as well as adjusted for attained Hgb levels)
Statistical measures of Hgb variability 26 weeks 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.)
Trial Locations
- Locations (1)
RRI
🇺🇸New York, New York, United States