Iron Dosing Pilot Study Using Model Predictive Control

University of Louisville10 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

DEVICE_FEASIBILITY

Masking

NONE

Enrollment

Conditions

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

Interventions

Model predictive controlDEVICE

Computer aided dose selection for the treatment of iron deficient anemia.

Model Predictive Control of Iron DosingDEVICE

Model Predictive Control of Iron Dosing

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * chronic kidney disease * anemia * receiving intravenous iron Exclusion Criteria: * none

Locations (1)

University of Louisville

Louisville, Kentucky, United States

Outcomes

Primary Outcomes

Percentage of tsat values within range

Tsat is measured as a percent saturation, desired range is 20 to 50%

Time frame: Monthly for 6 months

Secondary Outcomes

Iron dose over ride by physician

Number of recommended iron doses that the prescribing physician altered.

Time frame: Monthly for 6 months

Data from ClinicalTrials.gov

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