NCT03633656

Iron Dosing Pilot Study Using Model Predictive Control

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

This is a pilot study to test the utility of an integrated approach in the management of the anemia of chronic kidney disease through the administration of both an erythropoietic stimulating agent and iron. Subjects will be studied for 6 months during which all iron dosing will be recommended using a computer based tool using model predictive control. Comparisons will be made to the 6 months prior to enrollment in to the study.

Conditions

• Renal Insufficiency, Chronic
• Anemia, Iron Deficiency
• Anemia of Chronic Kidney Disease

Interventions

Type	Name	Description
DEVICE	Model predictive control	Computer aided dose selection for the treatment of iron deficient anemia.
DEVICE	Model Predictive Control of Iron Dosing	Model Predictive Control of Iron Dosing

Timeline

• Start date: 2019-02-01
• Primary completion: 2019-07-31
• Completion: 2019-08-30
• First posted: 2018-08-16
• Last updated: 2021-04-13

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study