Prospective Observational Study of Erythropoietin-Iron Interaction in Anemia of Renal Disease
Computational Approach to Personalized Anemia Management
2 other identifiers
observational
134
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2013
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 29, 2012
CompletedFirst Posted
Study publicly available on registry
November 1, 2012
CompletedStudy Start
First participant enrolled
January 1, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 5, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 5, 2021
CompletedOctober 27, 2022
October 1, 2022
8.4 years
October 29, 2012
October 25, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hemoglobin Concentration (g/dL)
Weekly Hemoglobin Concentration
52 weeks
Other Outcomes (2)
Transferrin Saturation (%)
52 weeks
Serum Ferritin (ng/mL)
52 weeks
Study Arms (3)
UofL Subjects
Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
Duke Subjects
Subjects undergoing Specimen Collection at Duke University, Durham, NC
WNERTA Subjects
Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA
Interventions
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
End Stage Renal Disease Patients undergoing hemodialysis treatments at: 1. University Kidney Center, Louisville, KY 2. Duke University, Durham, NC 3. WNERTA, Springfield, MA
You may qualify if:
- receiving or expected to receive ESA
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
University of Louisville, University Kidney Center
Louisville, Kentucky, 40202, United States
Western New England Renal and Transplant Associates
Springfield, Massachusetts, 01107, United States
Duke University
Durham, North Carolina, 27710, United States
Biospecimen
Blood, serum will be extracted and frozen for further analysis. Serum will be retained for up to 60 days.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Adam E Gaweda, Ph.D.
University of Louisville
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
October 29, 2012
First Posted
November 1, 2012
Study Start
January 1, 2013
Primary Completion
June 5, 2021
Study Completion
June 5, 2021
Last Updated
October 27, 2022
Record last verified: 2022-10