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Randomized Controlled Trial
. 2011 Dec;26(12):3980-6.
doi: 10.1093/ndt/gfr160. Epub 2011 Apr 19.

C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis

Simon D Roger  1 , Francesco Locatelli, Rainer P Woitas, Maurice Laville, Sheldon W Tobe, Robert Provenzano, Thomas A Golper, Prajej Ruangkanchanasetr, Ho Yung Lee, Kwan-Dun Wu, Michal Nowicki, Agnes Ladanyi, Alberto Martínez-Castelao, Ulrich Beyer, Frank C Dougherty
Affiliations
Randomized Controlled Trial

C.E.R.A. once every 4 weeks corrects anaemia and maintains haemoglobin in patients with chronic kidney disease not on dialysis

Simon D Roger et al. Nephrol Dial Transplant. 2011 Dec.

Abstract

Background: No previous randomized controlled studies have been reported examining de novo, once every 4 weeks (Q4W) administration of erythropoiesis-stimulating agents in chronic kidney disease (CKD) patients. We report results from a randomized multinational study that compared continuous erythropoietin receptor activator (C.E.R.A.) Q4W with darbepoetin alfa once weekly (QW) or every 2 weeks (Q2W) for the correction of anaemia in non-dialysis CKD patients.

Methods: Patients were randomized (1:1) to receive either 1.2 μg/kg C.E.R.A. Q4W or darbepoetin alfa QW/Q2W during a 20-week correction period and an 8-week evaluation period. Two primary end points were assessed: the haemoglobin (Hb) response rate and the change in average Hb concentration between baseline and evaluation.

Results: The Hb response rate for C.E.R.A. was 94.1%, significantly higher than the protocol-specified 60% response rate [95% confidence interval (CI): 89.1, 97.3; P < 0.0001] and comparable with darbepoetin alfa (93.5%; 95% CI: 88.4, 96.8; P < 0.0001). C.E.R.A. Q4W was non-inferior to darbepoetin alfa QW/Q2W, with similar mean Hb changes from baseline of 1.62 g/dL and 1.66 g/dL, respectively. Patients receiving C.E.R.A. showed a steady rise in Hb, with fewer patients above the target range during the first 8 weeks compared with darbepoetin alfa [39 patients (25.8%) versus 72 patients (47.7%); P < 0.0001]. Adverse event rates were comparable between the treatment groups.

Conclusion: C.E.R.A. Q4W successfully corrects anaemia and maintains stable Hb levels within the recommended target range in non-dialysis CKD patients.

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Figures

Fig. 1.
Fig. 1.
Study design.
Fig. 2.
Fig. 2.
Patient disposition.
Fig. 3.
Fig. 3.
Hb response rate in the ITT and per protocol populations.
Fig. 4.
Fig. 4.
Hb increase over time in the ITT population.
Fig. 5.
Fig. 5.
Percentage of patients with Hb levels >12 g/dL.
Fig. 6.
Fig. 6.
Comparison of median equivalent 4-week study drug dose over time.
See this image and copyright information in PMC

References

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