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

Study Overview
=================
Brief 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: a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy, a mathematical model will be established to correlate iron dose with iron markers.

Official Title
-----------------
Computational Approach to Personalized Anemia Management

Conditions
-----------------
Anemia of End Stage Renal Disease

Intervention / Treatment
-----------------
* Other: Specimen collection


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| UofL Subjects<br>Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY | Other: Specimen collection<br>* 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.<br>|
| Duke Subjects<br>Subjects undergoing Specimen Collection at Duke University, Durham, NC | Other: Specimen collection<br>* 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.<br>|
| WNERTA Subjects<br>Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA | Other: Specimen collection<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hemoglobin Concentration (g/dL) | Weekly Hemoglobin Concentration | 52 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anemia, Chronic Kidney Disease, Erythropoiesis Stimulating Agents, Erythropoietin, Iron, Iron Deficiency