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

Anemia of End Stage Renal Disease Clinical Trial

Official title:

Computational Approach to Personalized Anemia Management

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01719146
• Other study ID #: 12.0149
• Secondary ID: R01DK093832
• Status: Completed
• Start date: January 2013
• Est. completion date: June 5, 2021

Study information

• Verified date: October 2022
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: June 5, 2021
• Est. primary completion date: June 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anemia
• Anemia of End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

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.

Locations

Country	Name	City	State
United States	Duke University	Durham	North Carolina
United States	University of Louisville, University Kidney Center	Louisville	Kentucky
United States	Western New England Renal and Transplant Associates	Springfield	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
University of Louisville	National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Transferrin Saturation (%)	Weekly Transferrin Saturation	52 weeks
Other	Serum Ferritin (ng/mL)	Weekly Serum Ferritin	52 weeks
Primary	Hemoglobin Concentration (g/dL)	Weekly Hemoglobin Concentration	52 weeks