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

Hemoglobin Levels in Patients on Peritoneal Dialysis Receiving C.E.R.A. Versus Epoetin for Anemia of Chronic Kidney Disease (CKD): Pooled Analysis of Two Phase III 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: C.E.R.A. is a continuous erythropoietin (EPO) receptor activator currently under development for the treatment of anemia in CKD patients (pts) not on dialysis and CKD and pts receiving hemodialysis or peritoneal dialysis (PD). Methods: Pts on PD were pooled from 2 randomized, open-label Phase III trials comparing SC C.E.R.A. Q2W or Q4W to IV or SC EPO 1–3 times weekly for the treatment of anemia. A total of 67 pts on PD were enrolled in the 2 trials (23 in the C.E.R.A. Q2W group, 14 in the C.E.R.A. Q4W group, and 30 in the epoetin group). Pts received the study drugs in a dialysis unit during a 28-week dose titration period followed by an 8-week evaluation period. 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 EPO group. Mean Hb levels and change in mean Hb from baseline to evaluation for the intent-to-treat (ITT) populations are presented in the Table. Minor changes in Hb levels were observed between baseline and evaluation for the C.E.R.A. Q2W, C.E.R.A. Q4W, and EPO groups as follows: C.E.R.A. administered Q2W and Q4W was as effective as EPO in maintaining Hb between baseline and evaluation (C.E.R.A. Q2W: difference, 0.43; 95% CI: –0.34 to 1.19; and C.E.R.A. Q4W: difference, –0.019; 95% CI: –0.93 to 0.90).

Mean (SD) Hb Levels and Change in Hb from Baseline to Evaluation for the C.E.R.A. Q2W, Q4W, and Epoetin Groups (ITT Population) C.E.R.A. Epoetin Q2W (n=18) Q4W (n=11) 1-3x week (n=27) Baseline* 11.69 (0.74) 11.66 (0.70) 11.81 (0.69) Evaluation period 11.82 (1.23) 11.25 (1.53) 11.39 (1.15) Change from baseline to evaluation 0.15 (1.05) -0.39 (1.76) -0.35 (1.28) *Number of pts in the C.E.R.A. Q2W, Q4W, and epoetin groups=23, 14, and 30, respectively.

Conclusions: PD pts can successfully be converted directly from EPO 1-3 times weekly to C.E.R.A. Q2W and Q4W.






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