Iron Dosing Pilot Study Using Model Predictive Control

NCT ID: NCT03633656

Last Updated: 2021-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-02-01

Study Completion Date

2019-08-30

Brief Summary

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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

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Conditions

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

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DEVICE_FEASIBILITY

Blinding Strategy

NONE

Study Groups

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Treatment

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

Group Type EXPERIMENTAL

Model predictive control

Intervention Type DEVICE

Computer aided dose selection for the treatment of iron deficient anemia.

Model Predictive Control of Iron Dosing

Intervention Type DEVICE

Model Predictive Control of Iron Dosing

Interventions

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Model predictive control

Computer aided dose selection for the treatment of iron deficient anemia.

Intervention Type DEVICE

Model Predictive Control of Iron Dosing

Model Predictive Control of Iron Dosing

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

* chronic kidney disease
* anemia
* receiving intravenous iron

Exclusion Criteria

* none
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Louisville

OTHER

Sponsor Role lead

Responsible Party

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Alfred Jacobs

Assoc Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Alfred Jacobs, MD

Role: PRINCIPAL_INVESTIGATOR

University of Louisville

Locations

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University of Louisville

Louisville, Kentucky, United States

Site Status

Countries

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United States

Other Identifiers

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KDP001 IRB#18.0761

Identifier Type: -

Identifier Source: org_study_id

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