Iron Dosing Pilot Study Using Model Predictive Control

NCT03633656 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 10

Last updated 2021-04-13

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • University of Louisville

    lead OTHER

Principal Investigators

  • Alfred Jacobs, MD · University of Louisville

Study Design

Allocation
NA
Purpose
DEVICE_FEASIBILITY
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-07-31
Completion
2019-08-30
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03633656 on ClinicalTrials.gov