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

University of Louisville (UOFL)

Status: Completed

Conditions: Anemia of End Stage Renal Disease

Treatments: Other: Specimen collection

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01719146

12.0149

R01DK093832 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 134 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

134 participants in 3 patient groups

UofL Subjects

Description:

Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY

Treatment:

Other: Specimen collection

Duke Subjects

Description:

Subjects undergoing Specimen Collection at Duke University, Durham, NC

Treatment:

Other: Specimen collection

WNERTA Subjects

Description:

Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA

Treatment:

Other: Specimen collection