Trial record 9 of 3544 for:    Louisville

Iron Dosing Pilot Study Using Model Predictive Control

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03633656
Recruitment Status : Not yet recruiting
First Posted : August 16, 2018
Last Update Posted : August 16, 2018
Information provided by (Responsible Party):
Alfred Jacobs, University of Louisville

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.

Condition or disease Intervention/treatment Phase
Renal Insufficiency, Chronic Anemia, Iron Deficiency Anemia of Chronic Kidney Disease Device: Model predictive control Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Iron Dosing Pilot Study Using Model Predictive Control
Estimated Study Start Date : October 2018
Estimated Primary Completion Date : March 2019
Estimated Study Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Iron

Arm Intervention/treatment
Experimental: Treatment
Model predictive control recommendation of iron dosing in combination with an erythropoietic stimulating agent.
Device: Model predictive control
Computer aided dose selection for the treatment of iron deficient anemia.

Primary Outcome Measures :
  1. Percentage of tsat values within range [ Time Frame: Monthly for 6 months ]
    Tsat is measured as a percent saturation, desired range is 20 to 50%

Secondary Outcome Measures :
  1. Iron dose over ride by physician [ Time Frame: Monthly for 6 months ]
    Number of recommended iron doses that the prescribing physician altered.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • chronic kidney disease
  • anemia
  • receiving intravenous iron

Exclusion Criteria:

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03633656

Contact: Michael Brier, PhD 502-852-5757

United States, Kentucky
University of Louisville Not yet recruiting
Louisville, Kentucky, United States, 40202
Contact: Michael Brier, PhD    502-852-5757   
Sponsors and Collaborators
University of Louisville
Principal Investigator: Alfred Jacobs, MD University of Louisville

Responsible Party: Alfred Jacobs, Assoc Professor, University of Louisville Identifier: NCT03633656     History of Changes
Other Study ID Numbers: KDP001
First Posted: August 16, 2018    Key Record Dates
Last Update Posted: August 16, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Anemia, Iron-Deficiency
Renal Insufficiency
Hematologic Diseases
Urologic Diseases
Anemia, Hypochromic
Iron Metabolism Disorders
Metabolic Diseases