Anemia of End Stage Renal Disease
Conditions
Keywords
Anemia, Chronic Kidney Disease, Erythropoiesis Stimulating Agents, Erythropoietin, Iron, Iron Deficiency
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: 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.
Interventions
OTHERSpecimen 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.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
University of Louisville
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hemoglobin Concentration (g/dL) | 52 weeks | Weekly Hemoglobin Concentration |
Other
| Measure | Time frame | Description |
|---|---|---|
| Transferrin Saturation (%) | 52 weeks | Weekly Transferrin Saturation |
| Serum Ferritin (ng/mL) | 52 weeks | Weekly Serum Ferritin |
Countries
United States
Outcome results
None listed