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Intelligent Control Approach to Anemia Management

Primary Purpose

End-Stage Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
ESA Dose Adjustment per standard Anemia Management Protocol
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Sponsored by
University of Louisville
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for End-Stage Renal Disease focused on measuring End-Stage Renal Disease, Chronic Hemodialysis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Louisville Kidney Disease Program

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Control

Treatment

Arm Description

ESA Dose Adjustment per standard Anemia Management Protocol

ESA Dose Adjustment per "Smart Anemia Manager" Algorithm

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
December 11, 2007
Last Updated
November 15, 2017
Sponsor
University of Louisville
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT00572533
Brief Title
Intelligent Control Approach to Anemia Management
Official Title
Intelligent Control Approach to Anemia Management (AIM 4)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
April 2011 (undefined)
Primary Completion Date
April 2012 (Actual)
Study Completion Date
August 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End-Stage Renal Disease
Keywords
End-Stage Renal Disease, Chronic Hemodialysis

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
62 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Active Comparator
Arm Description
ESA Dose Adjustment per standard Anemia Management Protocol
Arm Title
Treatment
Arm Type
Experimental
Arm Description
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Intervention Type
Other
Intervention Name(s)
ESA Dose Adjustment per standard Anemia Management Protocol
Other Intervention Name(s)
AMP
Intervention Description
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
Intervention Type
Other
Intervention Name(s)
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Other Intervention Name(s)
SAM
Intervention Description
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm
Primary Outcome Measure Information:
Title
Percent Hb 10-12 g/dL
Description
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Percent Hb < 10 g/dL
Description
Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.
Time Frame
12 months
Title
Percent Hb > 12 g/dL
Description
Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.
Time Frame
12 months
Title
Mean Hb
Description
Mean Hemoglobin concentration over follow-up period
Time Frame
12 months
Title
ESA Dose
Description
Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria: ages 18 to 80, receiving dialysis treatment, receiving or expected to receive ESA treatment, adequacy of dialysis Kt/V >= 1.2, adequate iron stores (Ferritin > 200 ng/mL, TSat > 20%). Exclusion criteria: life expectancy less than 12 months, frequent uncontrolled blood loss, frequent dialyzer clotting, frequent access related problems, active infections, severe cardiac disability, coronary bypass within three months prior to the study documented resistance to ESA bone marrow suppression due to HIV, leukemia, or pharmacologic agents.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adam E Gaweda, Ph.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Louisville Kidney Disease Program
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States

12. IPD Sharing Statement

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Intelligent Control Approach to Anemia Management

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