Iron Dosing Pilot Study Using Model Predictive Control

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 Overview

• Status: Completed
• Conditions: Renal Insufficiency, Chronic; Anemia of Chronic Kidney Disease; Anemia, Iron Deficiency
• Intervention / Treatment: Device: Model predictive control; Device: Model Predictive Control of Iron Dosing

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• chronic kidney disease
• anemia
• receiving intravenous iron

Exclusion Criteria:

• none

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Device Feasibility
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.	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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Iron dose over ride by physician	Number of recommended iron doses that the prescribing physician altered.	Monthly for 6 months

Collaborators and Investigators

• Sponsor: University of Louisville
• Investigators: Principal Investigator: Alfred Jacobs, MD, University of Louisville

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2019
• Primary Completion (Actual): July 31, 2019
• Study Completion (Actual): August 30, 2019

Study Registration Dates

• First Submitted: August 14, 2018
• First Submitted That Met QC Criteria: August 14, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): April 13, 2021
• Last Update Submitted That Met QC Criteria: April 8, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Urologic Diseases; Hematologic Diseases; Anemia, Hypochromic; Iron Metabolism Disorders; Kidney Diseases; Renal Insufficiency, Chronic; Anemia, Iron-Deficiency; Renal Insufficiency; Anemia
• Other Study ID Numbers: KDP001 IRB#18.0761

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes