Intelligent Control Approach to Anemia Management

Not Applicable

Completed

• Conditions: End-Stage Renal Disease

• Registration Number: NCT00572533
• Lead Sponsor: University of Louisville

Brief Summary

First clinical evaluation of "Smart Anemia Manager" algorithm.

Detailed Description

The purpose of this single-center study is to test whether "Smart Anemia Manager" algorithm improves Hemoglobin stability compared to standard Anemia Management Protocol. Study site: Kidney Disease Program dialysis facility, University of Louisville, Louisville, KY.

Study Timeline

• Study First Submitted: 2007-12-11
• Study First Submitted QC: 2007-12-11
• Study First Posted: 2007-12-13
• Study Start: 2011-04
• Primary Completion: 2012-04
• Study Completion: 2012-08
• Results First Submitted: 2012-10-15
• Results First Submitted QC: 2012-12-19
• Results First Posted: 2012-12-20
• Status Verified: 2017-11
• Last Update Submitted: 2017-11-15
• Last Update Posted: 2017-12-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 62

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Percent Hb 10-12 g/dL	12 months	Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.

Secondary Outcome Measures

Name	Time	Method
Percent Hb < 10 g/dL	12 months	Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.
ESA Dose	12 months	Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)
Percent Hb > 12 g/dL	12 months	Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.
Mean Hb	12 months	Mean Hemoglobin concentration over follow-up period

Trial Locations

Locations (1)

University of Louisville Kidney Disease Program; 🇺🇸 Louisville, Kentucky, United States