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The CREATE trial--building the evidence.

K U Eckardt1,

  • 1Charité, Campus Virchow Klinikum, Humboldt-Universität, Berlin, Germany.

Nephrology, Dialysis, Transplantation : Official Publication of the European Dialysis and Transplant Association - European Renal Association
|May 23, 2001
PubMed
Summary

Early anemia treatment in renal patients may reduce cardiac risks. The CREATE trial investigates if starting epoetin beta sooner prevents left ventricular hypertrophy and cardiovascular events.

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Area of Science:

  • Nephrology
  • Cardiology
  • Clinical Trials

Background:

  • Renal anemia is a significant risk factor for left ventricular hypertrophy (LVH), heart failure, and mortality.
  • Partial correction of renal anemia can lead to partial regression of LVH.
  • Early initiation of anemia therapy might be optimal for reducing cardiac morbidity and mortality.

Purpose of the Study:

  • To investigate the effect of early anemia correction on cardiovascular risk reduction in patients not yet on renal replacement therapy.
  • To assess the impact of early epoetin beta treatment on the change in left ventricular mass index after one year.
  • To determine the effect of early anemia correction on the time to the first cardiovascular event.

Main Methods:

  • An open-label, randomized, multicenter trial (CREATE) involving 600 patients.
  • Two treatment arms: early intervention (epoetin beta initiated at Hb 11-12.5 g/dl, target 13-15 g/dl) and late intervention (epoetin beta initiated at Hb <10.5 g/dl, target 10.5-11.5 g/dl).
  • Event-driven study design with continuous evaluation and annual interim analysis.

Main Results:

  • The CREATE trial is designed to detect a one-third reduction in cardiovascular events.
  • The study aims to provide data on the efficacy of early versus late anemia correction on cardiac outcomes.
  • Interim analysis will be conducted annually.

Conclusions:

  • The CREATE trial will examine whether early anemia treatment prevents LVH development.
  • The study seeks to determine if early intervention reduces cardiovascular morbidity and offers other benefits in renal patients.
  • Findings will inform optimal timing for anemia therapy to mitigate cardiac risks.

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