Fatih ÖZDENER, Sedat ÜSTÜNDAĞ, Rümeyza KAZANCIOĞLU, Ekrem DOĞAN, Lütfullah ALTINTEPE, Murat DURANAY, Alaattin YILDIZ, Abdülkadir ÜNSAL, Vedat ÇELİK, Belda DURSUN, Ertuğrul AKBAŞ

Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Predialysis Patients

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.

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