Overview

This trial is active, not recruiting.

Condition anemia of end stage renal disease
Treatment specimen collection
Sponsor University of Louisville
Collaborator National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Start date January 2013
End date September 2018
Trial size 120 participants
Trial identifier NCT01719146, R01DK093832, R01DK093832-01A1

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model cohort
Time perspective prospective
Arm
Subjects undergoing Specimen Collection at University Kidney Center, University of Louisville, Louisville, KY
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.
Subjects undergoing Specimen Collection at Duke University, Durham, NC
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.
Subject undergoing Specimen Collection at Western New England Renal and Transplant Associates, Springfield, MA
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.

Primary Outcomes

Measure
Hemoglobin Concentration (g/dL)
time frame: 52 weeks

Secondary Outcomes

Measure
Reticulocyte Percentage (%)
time frame: 52 weeks
Reticulocyte Hemoglobin Equivalent, RetHe (pg)
time frame: 52 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Computational Approach to Personalized Anemia Management
Principal investigator Adam E Gaweda, Ph.D.
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.
Trial information was received from ClinicalTrials.gov and was last updated in December 2016.
Information provided to ClinicalTrials.gov by University of Louisville.