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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:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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
History of Changes
  Purpose

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.


Condition Intervention
Anemia of End Stage Renal Disease
 Other: Specimen collection

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Computational Approach to Personalized Anemia Management

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Hemoglobin Concentration (g/dL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Transferrin Saturation (%) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]
  • Serum Ferritin (ng/mL) [ Time Frame: 52 weeks ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

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


Estimated Enrollment: 120
Study Start Date: January 2013
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
UofL Subjects
Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
 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.
Duke Subjects
Subjects undergoing Specimen Collection at Duke University, Durham, NC
 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.
WNERTA Subjects
Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA
 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.

Detailed Description:

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

End Stage Renal Disease Patients undergoing hemodialysis treatments at:

  1. University Kidney Center, Louisville, KY
  2. Duke University, Durham, NC
  3. WNERTA, Springfield, MA
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01719146

Locations
United States, Kentucky
University of Louisville, University Kidney Center Recruiting
Louisville, Kentucky, United States, 40202
Contact: Amanda Moore     502-852-2290     amdalt01@exchange.louisville.edu    
Contact: Rachael Anderson     502-852-2290     rnande03@louisville.edu    
Principal Investigator: Adam E Gaweda, Ph.D.            
Sub-Investigator: George R Aronoff, MD            
United States, Massachusetts
Western New England Renal and Transplant Associates Recruiting
Springfield, Massachusetts, United States, 01107
Contact: Michael J Germain, M.D.     413-794-2604     Michael.Germain@baystatehealth.org    
Principal Investigator: Michael J Germain, MD            
United States, North Carolina
Duke University Recruiting
Durham, North Carolina, United States, 27710
Contact: Patrick H Pun, MD     919-660-6865     patrick.pun@duke.edu    
Principal Investigator: Patrick Pun, MD            
Sponsors and Collaborators
University of Louisville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Adam E Gaweda, Ph.D. University of Louisville
  More Information

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT01719146     History of Changes
Other Study ID Numbers: R01 DK093832-01A1, R01DK093832
Study First Received: October 29, 2012
Last Updated: January 25, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by University of Louisville:
Anemia
Chronic Kidney Disease
Erythropoiesis Stimulating Agents
 Erythropoietin
Iron
Iron Deficiency

Additional relevant MeSH terms:
Anemia
Kidney Diseases
Kidney Failure, Chronic
Hematologic Diseases
Urologic Diseases
Renal Insufficiency, Chronic
 Renal Insufficiency
Epoetin Alfa
Hematinics
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 22, 2013