Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease
NCT ID: NCT01719146
Last Updated: 2022-10-27
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
134 participants
OBSERVATIONAL
2013-01-31
2021-06-05
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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UofL Subjects
Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
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
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* 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
18 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
University of Louisville
OTHER
Responsible Party
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Adam Edward Gaweda
Associate Professor
Principal Investigators
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Adam E Gaweda, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Louisville
Locations
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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
Countries
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Other Identifiers
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12.0149
Identifier Type: -
Identifier Source: org_study_id
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