ISSN : 2146-3123
E-ISSN : 2146-3131

Subcutaneous C.E.R.A. for the Treatment of Chronic Renal Anemia in Predialysis Patients
Sedat Üstündağ 1, Ekrem Doğan 2, Murat Duranay 3, Rümeyza Kazancıoğlu 4, Vedat Çelik 5, Abdülkadir Ünsal 6, Lütfullah Altıntepe 7, Belda Dursun 8, Ertuğrul Akbaş 9, Alaattin Yıldız 10
1Department of Internal Medicine, Division of Nephrology, Trakya University School of Medicine, Edirne, Turkey
2Selahaddin Eyyubi University Faculty of Health Sciences, Diyarbakır, Turkey
3Clinic of Nephrology, Ankara Training and Research Hospital, Ankara, Turkey
4Clinic of Nephrology, Haseki Training and Research Hospital, İstanbul, Turkey
5Clinic of Nephrology, Okmeydanı Training and Research Hospital, İstanbul, Turkey
6Clinic of Nephrology, Sişli Etfal Training and Research Hospital, İstanbul, Turkey
7Clinic of Nephrology, Konya Training and Research Hospital, Konya, Turkey
8Department of Internal Medicine, Division of Nephrology, Pamukkale University School of Medicine, Denizli, Turkey
9Roche Pharmaceuticals, İstanbul, Turkey
10Department of Internal Medicine, Division of Nephrology, İstanbul University İstanbul School of Medicine, İstanbul, Turkey
DOI : 10.5152/balkanmedj.2016.141173
Pages : 322-330

Abstract

Background: We investigated the efficacy, safety and tolerability of once-monthly administration of C.E.R.A. in erythropoiesis stimulating agents (ESAs) naive predialysis patients with CKD for anemia treatment

Study 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 this study conducted between 12 August 2008 and 30 October 2009 in 9 centers across Turkey. The mean change in Hb concentration (g/dL) between baseline (week 0) and the efficacy evaluation period (EEP) was the primary efficacy parameter evaluated in three consecutive periods including a dose titration period (DTP; with initial 1.2 μg/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 Hb levels from baseline value of 9.4 (0.4) g/dL to time adjusted average level of 11.4 (0.7) g/dL in EEP in the per protocol (PP) population and from 9.3 (0.5) g/dL to 11.1 (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) and 1.7 (1.1) g/dL in the ITT population. The percentage of patients whose Hb concentrations remained within the target range of 10.0-12.0 g/dL throughout the EEP was 43.9% (95% CI: 28.5-60.3%) in the PP population and 38.7% (95% CI: 27.6% to 50.6%) in the ITP population. A total of 206 adverse events (AE) were reported in 77.0% of patients with hypertension (20%) as the most frequent AE.

Conclusion: Once-monthly subcutaneous C.E.R.A. administration is effective and safe in the treatment of anemia in pre-dialysis patients with CKD, who are not currently treated with ESAs. 

Keywords : C.E.R.A., chronic kidney disease, efficacy, hemoglobin levels, safety, tolerability
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