Iron Dosing Pilot Study Using Model Predictive Control

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03633656

Enrollment

Registered

2018-08-16

Start date

2019-02-01

Completion date

2019-08-30

Last updated

2021-04-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

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.

Interventions

DEVICEModel predictive control

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

DEVICEModel Predictive Control of Iron Dosing

Model Predictive Control of Iron Dosing

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DEVICE_FEASIBILITY

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

Inclusion criteria

* chronic kidney disease * anemia * receiving intravenous iron

Exclusion criteria

* none

Design outcomes

Primary

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

Secondary

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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026