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

Sponsor

University of Louisville (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT01719146

Collaborator

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

120

Enrollment

Locations

123.9

Duration (Months)

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Anemia of End Stage Renal Disease	Other: Specimen collection

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:

a mathematical model will be established to find biomarkers most descriptive with respect to erythropoiesis-iron synergy,
a mathematical model will be established to correlate iron dose with iron markers.

Study Design

Study Type:

Observational

Anticipated Enrollment :

120 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Computational Approach to Personalized Anemia Management

Study Start Date :

Jan 1, 2013

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Apr 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Arm

Intervention/Treatment

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

WNERTA Subjects

Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA

Other: Specimen collection

Outcome Measures

Primary Outcome Measures

Hemoglobin Concentration (g/dL) [52 weeks]
Weekly Hemoglobin Concentration

Other Outcome Measures

Transferrin Saturation (%) [52 weeks]
Weekly Transferrin Saturation
Serum Ferritin (ng/mL) [52 weeks]
Weekly Serum Ferritin

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	University of Louisville, University Kidney Center	Louisville	Kentucky	United States	40202
2	Western New England Renal and Transplant Associates	Springfield	Massachusetts	United States	01107
3	Duke University	Durham	North Carolina	United States	27710