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NCT03633656 · ClinicalTrials.gov registry record · Phase 4
Iron Dosing Pilot Study Using Model Predictive Control
A Phase 4 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency, sponsored by University of Louisville.
- Completed
- Registry status
- Phase 4
- Development phase
- 10
- Enrollment target
- 1
- Study location
NCT03633656: Completed Phase 4 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency, sponsored by University of Louisville.
NCT03633656 is a Phase 4 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency that has completed, run by University of Louisville. The registered enrollment target is 10 participants, below the 649-participant average among 14 other Renal Insufficiency, Chronic trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03633656, a Phase 4 study of Renal Insufficiency, Chronic and Anemia, Iron Deficiency, has completed, sponsored by University of Louisville.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 10 participants
- Enrollment target
- 1
- Study location
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.
Primary Outcome
Tsat is measured as a percent saturation, desired range is 20 to 50%
Conditions Studied
Interventions
- DEVICE Model predictive control
- DEVICE Model Predictive Control of Iron Dosing
Study Locations (1)
Kentucky
- University of Louisville - Louisville
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 10 participants |
| Start Date | 2019-02-01 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 4 |
What the finished NCT03633656 record still lists
NCT03633656 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 10 participants, a relatively small participant target, below the 649-participant average among 14 other Renal Insufficiency, Chronic trials with a reported enrollment target (98% lower).
The record links to 3 conditions, with Renal Insufficiency, Chronic appearing as the primary indexed condition, and to 2 interventions - of which Model predictive control is the first listed.
NCT03633656 reports a single indexed study location in Kentucky.
Frequently Asked Questions
What is clinical trial NCT03633656 about?
NCT03633656 is a clinical study titled "Iron Dosing Pilot Study Using Model Predictive Control". 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 ...
What is the current status of trial NCT03633656?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 10 participants. The study started on 2019-02-01. Estimated completion is 2019-08-30.
What conditions does trial NCT03633656 study?
This clinical trial studies the following conditions: Renal Insufficiency, Chronic, Anemia, Iron Deficiency, Anemia of Chronic Kidney Disease.
What interventions are being tested in trial NCT03633656?
The interventions under investigation include: Model predictive control (DEVICE), Model Predictive Control of Iron Dosing (DEVICE).
Who is sponsoring clinical trial NCT03633656?
This trial is sponsored by University of Louisville, which has 217 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03633656 being conducted?
This trial has 1 study location across Kentucky. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT03633656's enrollment target sits among peer trials
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participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Renal Insufficiency, Chronic trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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