NCT04360902

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

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Renal Research Institute · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• End Stage Renal Disease
• Renal Anemia
• Chronic Kidney Diseases

Interventions

Type	Name	Description
OTHER	Anemia Controller	Model Predictive Controller software (called "Anemia Controller") that utilizes our physiology-based erythropoiesis model to provide ESA dosing recommendations in order to guide a patient's Hgb level towards a predefined target value.

Timeline

• Start date: 2020-01-08
• Primary completion: 2020-12-01
• Completion: 2021-12-01
• First posted: 2020-04-24
• Last updated: 2020-04-24

Locations

1 site across 1 country: United States