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Intelligent Control Approach to Anemia Management

This study has been completed.
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
University of Louisville
ClinicalTrials.gov Identifier:
NCT00572533
First received: December 11, 2007
Last updated: December 19, 2012
Last verified: October 2012
History of Changes
  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 Blind (Subject, Caregiver)
Official Title: Intelligent Control Approach to Anemia Management (AIM 4)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Louisville:

Primary Outcome Measures:
  • Percent Hb 10-12 g/dL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.

  • Percent Hb > 12 g/dL [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.

  • Mean Hb [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Mean Hemoglobin concentration over follow-up period

  • ESA Dose [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: University of Louisville
ClinicalTrials.gov Identifier: NCT00572533     History of Changes
Other Study ID Numbers: K25 DK72085, K25DK072085, 1K25DK072085-01A2
Study First Received: December 11, 2007
Results First Received: October 15, 2012
Last Updated: December 19, 2012
Health Authority: United States: Federal Government

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

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

ClinicalTrials.gov processed this record on May 23, 2013