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NCT Number: NCT01719146

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

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.

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Key information

Conditions

Anemia of End Stage Renal Disease Anemia Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Hematologic Diseases Hemic and Lymphatic Diseases Iron Deficiencies Iron Metabolism Disorders Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Louisville, University Kidney Center, Louisville, Kentucky, United States

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About this study

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:

  • a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
  • a mathematical model will be established to correlate iron dose with iron markers.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Specimen Collection

Other

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.

Primary outcomes

  1. Hemoglobin Concentration (g/dL)

    Time frame: 52 weeks

    Weekly Hemoglobin Concentration

Other outcomes

  1. Transferrin Saturation (%)

    Time frame: 52 weeks

    Weekly Transferrin Saturation

  2. Serum Ferritin (ng/mL)

    Time frame: 52 weeks

    Weekly Serum Ferritin

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Official study title

Computational Approach to Personalized Anemia Management

Important dates

Study start
2013
Primary completion
2021
Study completion
2021
First posted
Nov 1, 2012
Registry last updated
Oct 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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