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

Computational Approach to Personalized Anemia Management

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.

Study Overview

• Status: Completed
• Conditions: Anemia of End Stage Renal Disease
• Intervention / Treatment: Other: Specimen collection

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 Type: Observational
• Enrollment (Actual): 134

Contacts and Locations

Study Locations

• United States
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville, University Kidney Center
  • Massachusetts
    • Springfield, Massachusetts, United States, 01107
      • Western New England Renal and Transplant Associates
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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

Description

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 Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
UofL Subjects; Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY	Other: Specimen 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.
Duke Subjects; Subjects undergoing Specimen Collection at Duke University, Durham, NC	Other: Specimen 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.
WNERTA Subjects; Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA	Other: Specimen 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.

What is the study measuring?

Primary Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Transferrin Saturation (%)	Weekly Transferrin Saturation	52 weeks
Serum Ferritin (ng/mL)	Weekly Serum Ferritin	52 weeks

Collaborators and Investigators

• Sponsor: University of Louisville
• Collaborators: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Investigators: Principal Investigator: Adam E Gaweda, Ph.D., University of Louisville

Study record dates

Study Major Dates

• Study Start: January 1, 2013
• Primary Completion (Actual): June 5, 2021
• Study Completion (Actual): June 5, 2021

Study Registration Dates

• First Submitted: October 29, 2012
• First Submitted That Met QC Criteria: October 29, 2012
• First Posted (Estimate): November 1, 2012

Study Record Updates

• Last Update Posted (Actual): October 27, 2022
• Last Update Submitted That Met QC Criteria: October 25, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Erythropoietin; Anemia; Iron; Chronic Kidney Disease; Iron Deficiency; Erythropoiesis Stimulating Agents
• Additional Relevant MeSH Terms: Urologic Diseases; Hematologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Diseases; Kidney Failure, Chronic; Anemia
• Other Study ID Numbers: 12.0149; R01DK093832 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED