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Iron Dosing Pilot Study Using Model Predictive Control

Primary Purpose

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

Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Model predictive control
Model Predictive Control of Iron Dosing
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional device feasibility trial for Renal Insufficiency, Chronic

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • chronic kidney disease
  • anemia
  • receiving intravenous iron

Exclusion Criteria:

  • none

Sites / Locations

  • University of Louisville

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.

Outcomes

Primary Outcome Measures

Percentage of tsat values within range
Tsat is measured as a percent saturation, desired range is 20 to 50%

Secondary Outcome Measures

Iron dose over ride by physician
Number of recommended iron doses that the prescribing physician altered.

Full Information

First Posted
August 14, 2018
Last Updated
April 8, 2021
Sponsor
University of Louisville
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1. Study Identification

Unique Protocol Identification Number
NCT03633656
Brief Title
Iron Dosing Pilot Study Using Model Predictive Control
Official Title
Iron Dosing Pilot Study Using Model Predictive Control
Study Type
Interventional

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2019 (Actual)
Primary Completion Date
July 31, 2019 (Actual)
Study Completion Date
August 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Insufficiency, Chronic, Anemia, Iron Deficiency, Anemia of Chronic Kidney Disease

7. Study Design

Primary Purpose
Device Feasibility
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Treatment
Arm Type
Experimental
Arm Description
Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.
Intervention Type
Device
Intervention Name(s)
Model predictive control
Intervention Description
Computer aided dose selection for the treatment of iron deficient anemia.
Intervention Type
Device
Intervention Name(s)
Model Predictive Control of Iron Dosing
Intervention Description
Model Predictive Control of Iron Dosing
Primary Outcome Measure Information:
Title
Percentage of tsat values within range
Description
Tsat is measured as a percent saturation, desired range is 20 to 50%
Time Frame
Monthly for 6 months
Secondary Outcome Measure Information:
Title
Iron dose over ride by physician
Description
Number of recommended iron doses that the prescribing physician altered.
Time Frame
Monthly for 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: chronic kidney disease anemia receiving intravenous iron Exclusion Criteria: none
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alfred Jacobs, MD
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Iron Dosing Pilot Study Using Model Predictive Control

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