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

This study is currently recruiting participants.
Verified October 2012 by University of Louisville
Sponsor:
Collaborator:
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT01719146
First received: October 29, 2012
Last updated: January 25, 2013
Last verified: October 2012

October 29, 2012
January 25, 2013
January 2013
March 2014   (final data collection date for primary outcome measure)
Hemoglobin Concentration (g/dL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01719146 on ClinicalTrials.gov Archive Site
  • Reticulocyte Percentage (%) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Reticulocyte Hemoglobin Equivalent, RetHe (pg) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
  • Transferrin Saturation (%) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Serum Ferritin (ng/mL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
Same as current
 
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 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.

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.
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

Blood, serum will be extracted and frozen for further analysis. Serum will be retained for up to 60 days.

Non-Probability Sample

End Stage Renal Disease Patients undergoing hemodialysis treatments at:

  1. University Kidney Center, Louisville, KY
  2. Duke University, Durham, NC
  3. WNERTA, Springfield, MA
Anemia of End Stage Renal Disease
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.
  • UofL Subjects
    Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
    Intervention: Other: Specimen collection
  • Duke Subjects
    Subjects undergoing Specimen Collection at Duke University, Durham, NC
    Intervention: Other: Specimen collection
  • WNERTA Subjects
    Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA
    Intervention: Other: Specimen collection
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
August 2016
March 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Not Provided
United States
 
NCT01719146
R01 DK093832-01A1, R01DK093832
No
University of Louisville
University of Louisville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Principal Investigator: Adam E Gaweda, Ph.D. University of Louisville
University of Louisville
October 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP