Iron Dosing Pilot Study Using Model Predictive Control

• Sponsor: University of Louisville (Other)
• Overall Status: Completed
• CT.gov ID: NCT03633656
• Collaborator: (none)
• Enrollment: 10
• Location: 1
• Arm: 1
• Actual Duration (Months): 6.9
• Patients Per Site Per Month: 1.4

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Renal Insufficiency, Chronic; Anemia, Iron Deficiency; Anemia of Chronic Kidney Disease	Device: Model predictive control; Device: Model Predictive Control of Iron Dosing	Phase 4

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Device Feasibility
• Official Title: Iron Dosing Pilot Study Using Model Predictive Control
• Actual Study Start Date: Feb 1, 2019
• Actual Primary Completion Date: Jul 31, 2019
• Actual Study Completion Date: Aug 30, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. Iron dose over ride by physician [Monthly for 6 months]

   Number of recommended iron doses that the prescribing physician altered.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• chronic kidney disease

• anemia

• receiving intravenous iron

Exclusion Criteria:

• none

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville	Louisville	Kentucky	United States	40202

Sponsors and Collaborators

• University of Louisville

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alfred Jacobs, Assoc Professor, University of Louisville
• ClinicalTrials.gov Identifier: NCT03633656
• Other Study ID Numbers: KDP001 IRB#18.0761
• First Posted: Aug 16, 2018
• Last Update Posted: Apr 13, 2021
• Last Verified: Apr 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Additional relevant MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Renal Insufficiency; Anemia; Anemia, Iron-Deficiency

Study Results

No Results Posted as of Apr 13, 2021