Intelligent Control Approach to Anemia Management

November 15, 2017 updated by: Adam Edward Gaweda, University of Louisville

Intelligent Control Approach to Anemia Management (AIM 4)

First clinical evaluation of "Smart Anemia Manager" algorithm.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

62

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Kentucky
      • Louisville, Kentucky, United States, 40202
        • University of Louisville Kidney Disease Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control
ESA Dose Adjustment per standard Anemia Management Protocol
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
Other Names:
  • AMP
Experimental: Treatment
ESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Other: 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
Other Names:
  • SAM

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Hb 10-12 g/dL
Time Frame: 12 months
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Louisville

Collaborators

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

  • Principal Investigator: Adam E Gaweda, Ph.D., University of Louisville

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2011

Primary Completion (Actual)

April 1, 2012

Study Completion (Actual)

August 1, 2012

Study Registration Dates

First Submitted

December 11, 2007

First Submitted That Met QC Criteria

December 11, 2007

First Posted (Estimate)

December 13, 2007

Study Record Updates

Last Update Posted (Actual)

December 13, 2017

Last Update Submitted That Met QC Criteria

November 15, 2017

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K25DK072085 (U.S. NIH Grant/Contract)
  • 1K25DK072085-01A2 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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