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NCT03633656 Clinical Trial

Iron Dosing Pilot Study Using Model Predictive Control

Renal Insufficiency, Chronic Clinical Trial

Official title:
Iron Dosing Pilot Study Using Model Predictive Control

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03633656
Other study ID # KDP001 IRB#18.0761
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date February 1, 2019
Est. completion date August 30, 2019

Study information
Verified date April 2021
Source University of Louisville
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 10
Est. completion date August 30, 2019
Est. primary completion date July 31, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria: - chronic kidney disease - anemia - receiving intravenous iron Exclusion Criteria: - none

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• Model predictive control
Computer aided dose selection for the treatment of iron deficient anemia.
• Model Predictive Control of Iron Dosing
Model Predictive Control of Iron Dosing

Locations
Country Name City State
United States University of Louisville Louisville Kentucky

Sponsors (1)
Lead Sponsor Collaborator
University of Louisville

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Percentage of tsat values within range Tsat is measured as a percent saturation, desired range is 20 to 50% Monthly for 6 months
Secondary Iron dose over ride by physician Number of recommended iron doses that the prescribing physician altered. Monthly for 6 months
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