NCT01719146

Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease

Computational Approach to Personalized Anemia Management

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 134 (actual)
• Sponsor: University of Louisville · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to prospectively collect data on doses of Erythropoietic Stimulating Agents (ESA) 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.

Detailed description

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.

Conditions

• Anemia of End Stage Renal Disease

Interventions

Type	Name	Description
OTHER	Specimen collection	At the beginning of each midweek hemodialysis session, a blood specimen (4 mL) will be drawn from the study subject. Out of this specimen a 1 mL serum sample will be frozen and stored. A 3 mL blood sample will be shipped overnight to WNERTA for laboratory testing.

Timeline

• Start date: 2013-01-01
• Primary completion: 2021-06-05
• Completion: 2021-06-05
• First posted: 2012-11-01
• Last updated: 2022-10-27

Locations

3 sites across 1 country: United States