Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Intelligent Control Approach to Anemia Management

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.
 
ClinicalTrials.gov Identifier: NCT00572533
Recruitment Status : Completed
First Posted : December 13, 2007
Results First Posted : December 20, 2012
Last Update Posted : December 13, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Adam Edward Gaweda, University of Louisville

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
First clinical evaluation of "Smart Anemia Manager" algorithm.

Condition or disease Intervention/treatment Phase
End-Stage Renal Disease Other: ESA Dose Adjustment per standard Anemia Management Protocol Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm Not Applicable

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 Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 62 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Care Provider)
Primary Purpose: Other
Official Title: Intelligent Control Approach to Anemia Management (AIM 4)
Study Start Date : April 2011
Actual Primary Completion Date : April 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 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


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  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 Outcome Measures :
  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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Adam E Gaweda, Ph.D. University of Louisville
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Adam Edward Gaweda, Associate Professor, University of Louisville
ClinicalTrials.gov Identifier: NCT00572533    
Other Study ID Numbers: K25DK072085 ( U.S. NIH Grant/Contract )
K25DK072085 ( U.S. NIH Grant/Contract )
1K25DK072085-01A2 ( U.S. NIH Grant/Contract )
First Posted: December 13, 2007    Key Record Dates
Results First Posted: December 20, 2012
Last Update Posted: December 13, 2017
Last Verified: November 2017
Keywords provided by Adam Edward Gaweda, University of Louisville:
End-Stage Renal Disease
Chronic Hemodialysis
Additional relevant MeSH terms:
Layout table for MeSH terms
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency