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Completed

NCT Number: NCT00572533

Intelligent Control Approach to Anemia Management

First clinical evaluation of "Smart Anemia Manager" algorithm.

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Key information

Conditions

End-stage Renal Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Kidney Failure, Chronic Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Louisville Kidney Disease Program

Louisville, Kentucky, 40202, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

ESA Dose Adjustment per standard Anemia Management Protocol

Other

Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility

Other names: AMP

ESA Dose Adjustment per "Smart Anemia Manager" Algorithm

Other

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

Primary outcomes

  1. 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 outcomes

  1. Percent Hb < 10 g/dL

    Time frame: 12 months

    Percentage of Hemoglobin concentrations measured (once per month) less than 10 g/dL.

  2. Percent Hb > 12 g/dL

    Time frame: 12 months

    Percentage of Hemoglobin concentrations measured (once per month) greater than 12 g/dL.

  3. Mean Hb

    Time frame: 12 months

    Mean Hemoglobin concentration over follow-up period

  4. ESA Dose

    Time frame: 12 months

    Mean ESA dose per patient-week. ESA used: Epoetin Alfa (IV)

Sponsors and collaborators

Lead sponsor

University of Louisville

Other

Collaborators

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

Registry information

Official study title

Intelligent Control Approach to Anemia Management (AIM 4)

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Dec 13, 2007
Registry last updated
Dec 13, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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