Iron Dosing Pilot Study Using Model Predictive Control

University of Louisville (UOFL)

Status and phase: Completed; Phase 4

Conditions: Anemia of Chronic Kidney Disease; Anemia, Iron Deficiency; Renal Insufficiency, Chronic

Treatments: Device: Model Predictive Control of Iron Dosing; Device: Model predictive control

Study type: Interventional

Funder types: Other

Identifiers

NCT03633656

KDP001 IRB#18.0761

Details and patient eligibility

About

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.

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• chronic kidney disease
• anemia
• receiving intravenous iron

Exclusion criteria

• none

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Treatment

Experimental group

Description:

Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.

Treatment:

Device: Model predictive control

Device: Model Predictive Control of Iron Dosing