Clinical trial NCT01719146: Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease
Official title: Computational Approach to Personalized Anemia Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anemia of End Stage Renal Disease
Keywords: Anemia
Chronic Kidney Disease
Erythropoiesis Stimulating Agents
Erythropoietin
Iron
Iron Deficiency
Lead sponsor: University of Louisville
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2012-11-01
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: End Stage Renal Disease Patients undergoing hemodialysis treatments at:

1. University Kidney Center, Louisville, KY
2. Duke University, Durham, NC
3. WNERTA, Springfield, MA

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.

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

Primary outcomes:
measure: Hemoglobin Concentration (g/dL)
timeFrame: 52 weeks
Secondary outcomes:
Other outcomes:
measure: Transferrin Saturation (%)
timeFrame: 52 weeks
measure: Serum Ferritin (ng/mL)
timeFrame: 52 weeks
Locations:
city: Louisville
country: United States
facility: University of Louisville, University Kidney Center
state: Kentucky
city: Springfield
country: United States
facility: Western New England Renal and Transplant Associates
state: Massachusetts
city: Durham
country: United States
facility: Duke University
state: North Carolina
Study officials:
affiliation: University of Louisville
name: Adam E Gaweda, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: