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Intelligent Control Approach to Anemia Management

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00572533
First Posted: December 13, 2007
Last Update Posted: December 20, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Louisville
  Purpose
First clinical evaluation of "Smart Anemia Manager" algorithm.

Condition Intervention
End-Stage Renal Disease Other: ESA Dose Adjustment per standard Anemia Management Protocol Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Official Title: Intelligent Control Approach to Anemia Management (AIM 4)

Resource links provided by NLM:


Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Percent Hb 10-12 g/dL [ Time Frame: 12 months ]
    Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.


Secondary Outcome Measures:
  • Percent Hb < 10 g/dL [ Time Frame: 12 months ]
    Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.

  • Percent Hb > 12 g/dL [ Time Frame: 12 months ]
    Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.

  • Mean Hb [ Time Frame: 12 months ]
    Mean Hemoglobin concentration over follow-up period

  • ESA Dose [ Time Frame: 12 months ]
    Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)


Enrollment: 62
Study Start Date: April 2011
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: SAM

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.
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00572533


Locations
United States, Kentucky
University of Louisville Kidney Disease Program
Louisville, Kentucky, United States, 40202
Sponsors and Collaborators
University of Louisville
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Investigators
Principal Investigator: Adam E Gaweda, Ph.D. University of Louisville
  More Information

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00572533     History of Changes
Other Study ID Numbers: K25DK072085 ( U.S. NIH Grant/Contract )
1K25DK072085-01A2 ( U.S. NIH Grant/Contract )
First Submitted: December 11, 2007
First Posted: December 13, 2007
Results First Submitted: October 15, 2012
Results First Posted: December 20, 2012
Last Update Posted: December 20, 2012
Last Verified: October 2012

Keywords provided by University of Louisville:
End-Stage Renal Disease
Chronic Hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency


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