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

NCT01719146 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 134

Last updated 2022-10-27

No results posted yet for this study

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.

Conditions

  • Anemia of End Stage Renal Disease

Interventions

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.

Sponsors & Collaborators

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

    collaborator NIH

  • University of Louisville

    lead OTHER

Principal Investigators

  • Adam E Gaweda, Ph.D. · University of Louisville

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-01-31
Primary Completion
2021-06-05
Completion
2021-06-05

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01719146 on ClinicalTrials.gov