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Perit Dial Int 27(Supplement_3): 13- 2007
© 2007 International Society for Peritoneal Dialysis
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Clinical Experience

Safety and Tolerability of C.E.R.A. in Chronic Kidney Disease (CKD) Patients Receiving Peritoneal Dialysis: Pooled Data from Two Phase III Maintenance Trials

J. Burkart1, R. Beswick2 and J. Moran3

Internal Medicine/Nephrol,1 Wake Forest Univ Baptist Med Cntr, Wake Forest, North Carolina; Roche Laboratories,2 Nutley, New Jersey; WellBound, Inc.,3 Mountainview, California, USA.

Objective: This analysis of 2 Phase III clinical trials reviews the safety and tolerability of C.E.R.A., a continuous erythropoietin receptor activator, for treating anemia of CKD in patients (pts) receiving peritoneal dialysis (PD). Methods: Pts were randomized to receive either C.E.R.A. or epoetin-alfa/beta (EPO). C.E.R.A. was administered SC once every 2 or 4 weeks for 36 or 52 weeks of maintenance therapy (hemoglobin range 10–13.5 g/dL); EPO was administered IV or SC 1–3 times per week. Pts received the study drugs for a 28-week dose titration period followed by an 8-week evaluation period. Pooled data from these Phase III trials provided a PD population of 67 pts: 37 in the C.E.R.A. group and 30 in the EPO group. Results: The demographics of the C.E.R.A. and EPO groups were similar, with the exception of more females (51% vs 37%) and fewer African-Americans (14% vs 23%) in the C.E.R.A. group versus the reference population. The presence of risk factors for vascular events, including the prevalence of hypertension, diabetes, and congestive heart failure (CHF), was similar to previous studies in this therapeutic area, with no notable differences between the 2 treatment arms. The most common comorbidities in the C.E.R.A. and EPO groups were hypertension (89% vs 93%), hyperlipidemia (62% vs 60%), diabetes (27% vs 30%), and CHF (24% vs 20%). The percentage of pts experiencing ≥1 adverse events (AEs) was similar between the C.E.R.A. and EPO groups (94.6% vs 93.3%). The most frequent AEs (≥10% in both C.E.R.A. and reference populations) were infection (including peritonitis, peritonitis bacterial and catheter site infection) (43.2% vs 43.3%), diarrhea (13.5% vs 16.7%), hypertension (13.5% vs 16.7%), nasopharyngitis (24% vs 10%), and upper respiratory tract infection (16% vs 10%). Rates of serious AEs were 27% and 46.7% for the C.E.R.A. and EPO groups respectively. AEs leading to withdrawal were similar between the C.E.R.A. and EPO groups (27% vs 26.7%). Conclusions: Administration of C.E.R.A. for the treatment of anemia associated with CKD, in pts receiving PD, has a safety profile consistent with that of reference ESAs.






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