N/A N=62 Randomized Double-blind Other

Intelligent Control Approach to Anemia Management

End-Stage Renal Disease

Bottom Line

View on ClinicalTrials.gov: NCT00572533 ↗

Enrolled (actual)

Serious AEs

59.7%

Results posted

Dec 2012

Primary outcome: Primary: Percent Hb 10-12 g/dL — 61.9; 72.5 Percent

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: ESA Dose Adjustment per standard Anemia Management Protocol (Other); ESA Dose Adjustment per "Smart Anemia Manager" Algorithm (Other)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: University of Louisville
Primary completion: Apr 2012

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Hb 10-12 g/dL	61.9; 72.5	—
SECONDARY Percent Hb < 10 g/dL	24.7; 11.8	—
SECONDARY Percent Hb > 12 g/dL	13.4; 15.7	—
SECONDARY Mean Hb	10.7; 11.0	—
SECONDARY ESA Dose	3,033; 3,704	—

Summary

First clinical evaluation of "Smart Anemia Manager" algorithm.

Eligibility Criteria

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00572533). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.