Non-Dialysis-Dependent Chronic Kidney Disease Clinical Trial
Official title:
A Phase 3, Randomized, Open-Label, Active-Controlled, Multicenter, Non-Inferiority Study to Evaluate the Efficacy and Safety of Pegol-Sihematide for Anemia in Patients With Non-Dialysis-Dependent Chronic Kidney Disease
The primary objective of this study is to evaluate the safety and efficacy of Pegol-Sihematide, as compared with recombinant human erythropoietin injection (CHO Cell), ESPO, in anemia treatment in patients with non-dialysis-dependent chronic kidney disease.
This is a phase 3, randomized, multicenter, open-label, active-controlled, non-inferiority trial to evaluate the safety and efficacy of Pegol-Sihematide versus ESPO. Study included a period of 4 weeks for screening, 16 weeks for dose adjustment, 8 weeks for evaluation, and 28 weeks for extensional treatment period. Eligible patients were centrally allocated in a 2:1 ratio to receive Pegol-Sihematide subcutaneously once every 4 weeks, starting at 0.04 mg per kilogram of body weight, or ESPO once every 1 week or 2 weeks, starting dose of 6000 IU per week. Doses of both drugs were adjusted to achieve and maintain hemoglobin levels between 10.0 and 12.0 g per deciliter for 52 weeks or more. The primary efficacy end point was the mean change from the baseline hemoglobin level to the mean level during the evaluation period; non-inferiority was established if the lower limit of the two-sided 95% confidence interval was -1.0 g per deciliter or higher. Cardiovascular safety was evaluated on the basis of an adjudicated composite end point. ;
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