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


METHODS
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.


CONCLUSIONS
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.
Department of Internal Medicine, Division of Nephrology, Trakya University School of Medicine, Edirne, Turkey.
Sedat
S
Üstündağ
Selahaddin Eyyubi University Faculty of Health Sciences, Diyarbakır, Turkey.
Ekrem
E
Doğan
Clinic of Nephrology, Ankara Training and Research Hospital, Ankara, Turkey.
Murat
M
Duranay
Clinic of Nephrology, Haseki Training and Research Hospital, İstanbul, Turkey.
Rümeyza
R
Kazancıoğlu
Clinic of Nephrology, Okmeydanı Training and Research Hospital, İstanbul, Turkey.
Vedat
V
Çelik
Clinic of Nephrology, Sişli Etfal Training and Research Hospital, İstanbul, Turkey.
Abdülkadir
A
Ünsal
Clinic of Nephrology, Konya Training and Research Hospital, Konya, Turkey.
Lütfullah
L
Altıntepe
Department of Internal Medicine, Division of Nephrology, Pamukkale University School of Medicine, Denizli, Turkey.
Belda
B
Dursun
Roche Pharmaceuticals, İstanbul, Turkey.
Ertuğrul
E
Akbaş
Roche Pharmaceuticals, İstanbul, Turkey.
Fatih
F
Özdener
Department of Internal Medicine, Division of Nephrology, İstanbul University İstanbul School of Medicine, İstanbul, Turkey.
Alaattin
A
Yıldız
C.E.R.A.; chronic kidney disease; efficacy; hemoglobin levels; safety; tolerability