Iron Dosing Pilot Study Using Model Predictive Control

Phase 4

Completed

• Conditions: Renal Insufficiency, Chronic; Anemia of Chronic Kidney Disease; Anemia, Iron Deficiency
• Interventions: Device: Model predictive control; Device: Model Predictive Control of Iron Dosing

• Registration Number: NCT03633656
• Lead Sponsor: University of Louisville

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-14
• Study First Submitted QC: 2018-08-14
• Study First Posted: 2018-08-16
• Study Start: 2019-02-01
• Primary Completion: 2019-07-31
• Study Completion: 2019-08-30
• Status Verified: 2021-04
• Last Update Submitted: 2021-04-08
• Last Update Posted: 2021-04-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

• chronic kidney disease
• anemia
• receiving intravenous iron

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Treatment	Model predictive control	Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.
Treatment	Model Predictive Control of Iron Dosing	Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.

Primary Outcome Measures

Name	Time	Method
Percentage of tsat values within range	Monthly for 6 months	Tsat is measured as a percent saturation, desired range is 20 to 50%

Secondary Outcome Measures

Name	Time	Method
Iron dose over ride by physician	Monthly for 6 months	Number of recommended iron doses that the prescribing physician altered.

Trial Locations

Locations (1)

University of Louisville; 🇺🇸 Louisville, Kentucky, United States