Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Anemia |
| Therapuetic Areas: | Hematology, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 10/27/2017 |
| Start Date: | January 2013 |
| End Date: | September 2018 |
Computational Approach to Personalized Anemia Management
The purpose of this study is to prospectively collect data on doses of Erythropoietic
Stimulating Agents and Intravenous Iron, and the markers of erythropoietic activity and iron
status. These data will be used to derive mathematical models which will subsequently guide
dosing of both agents, such that a desired therapeutic outcome is achieved in every patient,
while minimizing patient exposure to both agents.
Stimulating Agents and Intravenous Iron, and the markers of erythropoietic activity and iron
status. These data will be used to derive mathematical models which will subsequently guide
dosing of both agents, such that a desired therapeutic outcome is achieved in every patient,
while minimizing patient exposure to both agents.
Data will be collected from 120 subjects undergoing hemodialysis treatment at 3 clinical
sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek
treatment (Wed/Thu) to measure:
Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte
Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin
Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum
Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor
Weekly ESA and Iron dose delivered will also be recorded.
From these data:
1. a mathematical model will be established to find biomarkers most descriptive with
respect to erythropoiesis-iron synergy,
2. a mathematical model will be established to correlate iron dose with iron markers.
sites across United States (40 per site).5.5 mL blood specimen will be drawn during midweek
treatment (Wed/Thu) to measure:
Hemoglobin Concentration Hematocrit Red Blood Cell Count Platelet Count Reticulocyte
Percentage Reticulocyte Hemoglobin Mean Cellular Hemoglobin Mean Cellular Hemoglobin
Concentration Mean Cell Volume Red Cell Volume Distribution Width Mean Platelet Volume Serum
Iron Serum Ferritin Transferrin Saturation Hepcidin Soluble Transferrin Receptor
Weekly ESA and Iron dose delivered will also be recorded.
From these data:
1. a mathematical model will be established to find biomarkers most descriptive with
respect to erythropoiesis-iron synergy,
2. a mathematical model will be established to correlate iron dose with iron markers.
Inclusion Criteria:
- receiving or expected to receive ESA
Exclusion Criteria:
- life expectancy less than 12 months
- frequent (once or more per month w/in last 6 months) uncontrolled blood loss
- frequent (once or more per month w/in last 6 months) hospitalization
- frequent (once or more per month w/in last 6 months) access complications
We found this trial at
3
sites
Click here to add this to my saved trials
Duke University Younger than most other prestigious U.S. research universities, Duke University consistently ranks among...
Click here to add this to my saved trials
Click here to add this to my saved trials