Intelligent Control Approach to Anemia Management
2 other identifiers
interventional
62
1 country
1
Brief Summary
First clinical evaluation of "Smart Anemia Manager" algorithm.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Apr 2011
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 11, 2007
CompletedFirst Posted
Study publicly available on registry
December 13, 2007
CompletedStudy Start
First participant enrolled
April 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2012
CompletedResults Posted
Study results publicly available
December 20, 2012
CompletedDecember 13, 2017
November 1, 2017
1 year
December 11, 2007
October 15, 2012
November 15, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percent Hb 10-12 g/dL
Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.
12 months
Secondary Outcomes (4)
Percent Hb < 10 g/dL
12 months
Percent Hb > 12 g/dL
12 months
Mean Hb
12 months
ESA Dose
12 months
Study Arms (2)
Control
ACTIVE COMPARATORESA Dose Adjustment per standard Anemia Management Protocol
Treatment
EXPERIMENTALESA Dose Adjustment per "Smart Anemia Manager" Algorithm
Interventions
Amount of ESA dose adjustment in Units per week guided by standard Anemia Management Protocol in use at the facility
Amount of ESA dose adjustment in Units per week individualized to subject's dose-response profile guided by "Smart Anemia Manager" algorithm
Eligibility Criteria
You may qualify if:
- 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%).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Louisville Kidney Disease Program
Louisville, Kentucky, 40202, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Limitations and Caveats
1. Single-center design 2. Small sample size 3. Homogenous population 4. Only maintenance dosing phase tested
Results Point of Contact
- Title
- Adam E Gaweda
- Organization
- University of Louisville
Study Officials
- PRINCIPAL INVESTIGATOR
Adam E Gaweda, Ph.D.
University of Louisville
Publication Agreements
- PI is Sponsor Employee
- Yes
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, CARE PROVIDER
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor
Study Record Dates
First Submitted
December 11, 2007
First Posted
December 13, 2007
Study Start
April 1, 2011
Primary Completion
April 1, 2012
Study Completion
August 1, 2012
Last Updated
December 13, 2017
Results First Posted
December 20, 2012
Record last verified: 2017-11