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CompletedNCT00572533Updated Dec 13, 2017Results posted

Intelligent Control Approach to Anemia Management

An interventional study of ESA Dose Adjustment per standard Anemia Management Protocol and ESA Dose Adjustment per "Smart Anemia Manager" Algorithm in End-Stage Renal Disease, sponsored by University of Louisville. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-12-13.

Sponsored by University of Louisville · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
62
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study summary

First clinical evaluation of "Smart Anemia Manager" algorithm.

Read the 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.

02

Conditions studied

  • End-Stage Renal Disease

Keywords

  • End-Stage Renal Disease
  • Chronic Hemodialysis
03

In context

Kidney Diseases

3,840 studies on the registry are indexed under Kidney Diseases; 500 are open to participants now.

This study's enrollment of 62 is below the median of 70 across 2,640 interventional studies indexed under Kidney Diseases.

Browse Kidney Diseases studies →

Lead sponsor

University of Louisville is the lead sponsor of 284 studies on the registry; 53 are open to participants now.

Of its 20 completed or terminated interventional studies of FDA-regulated products, 7 (35%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
62 participants (actual)

Study arms

  • Active comparator
    Control

    ESA Dose Adjustment per standard Anemia Management Protocol

    Other: ESA Dose Adjustment per standard Anemia Management Protocol

  • Experimental
    Treatment

    ESA Dose Adjustment per "Smart Anemia Manager" Algorithm

    Other: ESA Dose Adjustment per "Smart Anemia Manager" Algorithm

Interventions

  • OtherESA 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

    Also known as: AMP

  • OtherESA 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

    Also known as: SAM

06

What researchers measure

Primary outcomes

  1. Percent Hb 10-12 g/dL

    Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.

    Time frame: 12 months

Secondary outcomes

  1. Percent Hb < 10 g/dL

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

    Time frame: 12 months

  2. Percent Hb > 12 g/dL

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

    Time frame: 12 months

  3. Mean Hb

    Mean Hemoglobin concentration over follow-up period

    Time frame: 12 months

  4. ESA Dose

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

    Time frame: 12 months

07

Results

Posted Dec 20, 2012
Limitations and caveats
1. Single-center design 2. Small sample size 3. Homogenous population 4. Only maintenance dosing phase tested

Participant flow

Participant flow — Overall Study
MilestoneControlTreatment
Started3131
Completed2428
Not completed73
Withdrew: Death41
Withdrew: Received kidney transplant21
Withdrew: Social issues10
Withdrew: Transfer out of facility01

Outcome measures

PrimaryPercent Hb 10-12 g/dL

Percentage of Hemoglobin concentrations measured (once per month) between 10 and 12 g/dL.

Time frame:
12 months
Reported as:
Number · Percent
Percent Hb 10-12 g/dL
PercentControlTreatment
Percent Hb 10-12 g/dL61.972.5
SecondaryPercent Hb < 10 g/dL

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

Time frame:
12 months
Reported as:
Number · Percent
Percent Hb < 10 g/dL
PercentControlTreatment
Percent Hb < 10 g/dL24.711.8
Post-hocTransfusion Events

Number of Transfusion Events

Time frame:
12 months
Reported as:
Number · Events
Transfusion Events
EventsControlTreatment
Transfusion Events136
SecondaryPercent Hb > 12 g/dL

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

Time frame:
12 months
Reported as:
Number · Percent
Percent Hb > 12 g/dL
PercentControlTreatment
Percent Hb > 12 g/dL13.415.7
SecondaryMean Hb

Mean Hemoglobin concentration over follow-up period

Time frame:
12 months
Reported as:
Mean · g/dL
Mean Hb
g/dLControlTreatment
Mean Hb10.7 ± 1.511.0 ± 1.2
SecondaryESA Dose

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

Time frame:
12 months
Reported as:
Mean · IU
ESA Dose
IUControlTreatment
ESA Dose3,033 ± 3,5923,704 ± 5,221
Post-hocSubjects Receiving Transfusion

Number of Subjects receiving Transfusion

Time frame:
12 months
Reported as:
Number · Participants
Subjects Receiving Transfusion
ParticipantsControlTreatment
Subjects Receiving Transfusion85
Post-hocRBC Units Transfused

Total number of RBC units transfused

Time frame:
12 months
Reported as:
Number · RBC Units
RBC Units Transfused
RBC UnitsControlTreatment
RBC Units Transfused3121

Adverse events

Collected over 04/01/2011 - 03/31/2012. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Control—19/31 (61.3%)17/31 (54.8%)
Treatment—18/31 (58.1%)16/31 (51.6%)
Most frequent serious events
Most frequent serious events
EventControlTreatment
HospitalizationGeneral disorders18/3118/31
Composite Safety Event (ACM, MI, CVA, CHF)General disorders6/3110/31
Most frequent other events
Most frequent other events
EventControlTreatment
Vascular Access EventSurgical and medical procedures17/3116/31
InfectionGeneral disorders5/316/31

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)ControlTreatmentTotal
<=18 years000
Between 18 and 65 years242751
>=65 years7411
Age, Continuous
Age, Continuous(years)ControlTreatmentTotal
Mean57 ± 1057 ± 957 ± 9
Sex: Female, Male
Sex: Female, Male(Participants)ControlTreatmentTotal
Female91120
Male222042
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)ControlTreatmentTotal
American Indian or Alaska Native000
Asian000
Native Hawaiian or Other Pacific Islander000
Black or African American202141
White111021
More than one race000
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(participants)ControlTreatmentTotal
United States313162
Diabetes
Diabetes(Participants)ControlTreatmentTotal
Diabetes171835
No Diabetes141327
Congestive Heart Failure (CHF)
Congestive Heart Failure (CHF)(Subjects)ControlTreatmentTotal
CHF6814
No CHF252348
Vascular Access Type
Vascular Access Type(Participants)ControlTreatmentTotal
Fistula202141
Catheter639
Graft5712

2 further baseline measures are reported on the registry.

08

Study locations

1 site
  • University of Louisville Kidney Disease Program
    Louisville, Kentucky 40202, United States
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 13, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00572533
Lead sponsor
University of Louisville
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Responsible party
Adam Edward Gaweda (Associate Professor, University of Louisville) — Principal investigator
First posted
Dec 13, 2007
Start date
Apr 2011
Primary completion
Apr 2012
Completion
Aug 2012
Results posted
Dec 20, 2012
Last update
Dec 13, 2017

Study contacts

Adam E Gaweda, Ph.D.
principal investigator · University of Louisville

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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