AI Summary & Key Takeaways
AI InsightThe percentage ofpatients whose Hb concentrations remained within thetarget range of 10.0-12.0 g/dL throughout the EEP was43.9% (95% CI: 28.5-60.3%) in the PP population and38.7% (95% CI: 27.6% to 50.6%) in the ITP population.A total of 206 adverse events (AE) were reported in77.0% of patients with hypertension (20%) as the mostfrequent AE.Conclusion: Once-monthly subcutaneous C.E.R.A.administration is effective and safe in the treatment ofanemia in pre-dialysis patients with CKD, who are notcurrently treated with ESAs.
📌 3 Key Takeaways
Abstract
Background: We investigated the efficacy, safety andtolerability of once-monthly administration of C.E.R.A.in erythropoiesis stimulating agents (ESAs) naive predialysispatients with CKD for anemia treatmentStudy Design: Single arm, open label study.Methods: A total of 75 patients (mean (SD) age was 52.8(16.4) years, 76.0% were female) were included in thisstudy conducted between 12 August 2008 and 30 October2009 in 9 centers across Turkey. The mean change inHb concentration (g/dL) between baseline (week 0) andthe efficacy evaluation period (EEP) was the primary efficacyparameter evaluated in three consecutive periodsincluding a dose titration period (DTP; with initial 1.2?g/kg dose of C.E.R.A., subcutaneously, 28 weeks), EEP(8 weeks) and a long-term safety period (16 weeks).Results: Our analysis revealed an improvement in Hblevels from baseline value of 9.4 (0.4) g/dL to time adjustedaverage level of 11.4 (0.7) g/dL in EEP in theper protocol (PP) population and from 9.3 (0.5) g/dL to11.1 (1.0) g/dL in intent-to-treat (ITT) population. Mean(SD) change in Hb levels from baseline to EEP was 2.0(0.7) g/dl in the PP population (primary endpoint) and1.7 (1.1) g/dL in the ITT population. The percentage ofpatients whose Hb concentrations remained within thetarget range of 10.0-12.0 g/dL throughout the EEP was43.9% (95% CI: 28.5-60.3%) in the PP population and38.7% (95% CI: 27.6% to 50.6%) in the ITP population.A total of 206 adverse events (AE) were reported in77.0% of patients with hypertension (20%) as the mostfrequent AE.Conclusion: Once-monthly subcutaneous C.E.R.A.administration is effective and safe in the treatment ofanemia in pre-dialysis patients with CKD, who are notcurrently treated with ESAs.