Intelligent Control Approach to Anemia Management

End-Stage Renal Disease Clinical Trial

Official title:

Intelligent Control Approach to Anemia Management (AIM 4)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00572533
• Other study ID #: K25DK072085
• Secondary ID: K25DK0720851K25D
• Status: Completed
• Phase: N/A
• First received: December 11, 2007
• Last updated: November 15, 2017
• Start date: April 2011
• Est. completion date: August 2012

Study information

• Verified date: November 2017
• Source: University of Louisville
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

First clinical evaluation of "Smart Anemia Manager" algorithm.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 62
• Est. completion date: August 2012
• Est. primary completion date: April 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion criteria:

1. ages 18 to 80,

2. receiving dialysis treatment,

3. receiving or expected to receive ESA treatment,

4. adequacy of dialysis Kt/V >= 1.2,

5. adequate iron stores (Ferritin > 200 ng/mL, TSat > 20%).

Exclusion criteria:

1. life expectancy less than 12 months,

2. frequent uncontrolled blood loss,

3. frequent dialyzer clotting,

4. frequent access related problems,

5. active infections,

6. severe cardiac disability,

7. coronary bypass within three months prior to the study

8. documented resistance to ESA

9. bone marrow suppression due to HIV, leukemia, or pharmacologic agents.

Related Conditions & MeSH terms

• End-Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic

Intervention

Other:
• ESA Dose Adjustment per standard Anemia Management Protocol
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
• ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm

Locations

Country	Name	City	State
United States	University of Louisville Kidney Disease Program	Louisville	Kentucky

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