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

Completed

• Conditions: Anemia of End Stage Renal Disease
• Interventions: Other: Specimen collection

• Registration Number: NCT01719146
• Lead Sponsor: University of Louisville

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.

Study Timeline

• Study First Submitted: 2012-10-29
• Study First Submitted QC: 2012-10-29
• Study First Posted: 2012-11-01
• Study Start: 2013-01
• Primary Completion: 2021-06-05
• Study Completion: 2021-06-05
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 134

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
UofL Subjects	Specimen collection	Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
WNERTA Subjects	Specimen collection	Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA
Duke Subjects	Specimen collection	Subjects undergoing Specimen Collection at Duke University, Durham, NC

Primary Outcome Measures

Name	Time	Method
Hemoglobin Concentration (g/dL)	52 weeks	Weekly Hemoglobin Concentration

Trial Locations

Locations (3)

University of Louisville, University Kidney Center; 🇺🇸 Louisville, Kentucky, United States

Western New England Renal and Transplant Associates; 🇺🇸 Springfield, Massachusetts, United States

Duke University; 🇺🇸 Durham, North Carolina, United States