Non-Inferiority Trials in Anemia Treatment for Chronic Kidney Disease

Introduction to Non-Inferiority Trials

The null hypothesis in a non-inferiority trial states that the novel therapy is worse than the standard therapy by the prespecified margin, as defined by the Kidney International guidelines 1
For non-inferiority to be established, the lower bound of the 95% confidence interval must not cross the pre-specified non-inferiority margin, according to the Kidney International guidelines 1
In the context of anemia treatment for CKD patients, the entire confidence interval must be examined in relation to the non-inferiority margin, not just the point estimate, as recommended by the Kidney International guidelines 1

The new medication is inferior to the standard treatment for improving hemoglobin concentrations in patients with chronic kidney disease and anemia, with an observed difference between treatments of -0.97 g/dL and a 95% Confidence Interval of -1.32 g/dL to -0.72 g/dL, providing strong evidence of inferiority 1