The CREATE trial--building the evidence

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.