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NDT Advance Access published online on September 12, 2006
Nephrology Dialysis Transplantation, doi:10.1093/ndt/gfl483
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© The Author [2006]. Published by Oxford University Press on behalf of ERA-EDTA. All rights reserved. For Permissions, please email: journals.permissions@oxfordjournals.org
Received September 27, 2004
Accepted July 18, 2006

Original Article

Is early treatment of anaemia with epoetin-{alpha} beneficial to pre-dialysis chronic kidney disease patients? Results of a multicentre, open-label, prospective, randomized, comparative group trial

Iain C. Macdougall 1 *, R. Mark Temple 2, and Jonathan T. C. Kwan 3, on behalf of the EPO-GBR-2 Study Group

1 The Renal Unit, King's College Hospital, Denmark Hill, London SE5 9RS, UK
2 Heartlands Hospital, Renal Unit, Bordesley Green, Birmingham B9 5SS, UK
3 SW Thames Renal & Transplant Unit, St Helier Hospital, Carlshalton, Surrey SM5 1AA, UK

* To whom correspondence should be addressed.
Iain C. Macdougall, E-mail: Iain.Macdougall{at}kingsch.nhs.uk



  Abstract

Background. This multicentre, open-label prospective, randomized, comparative-group study evaluated the effects of maintaining haemoglobin (Hb) in pre-dialysis chronic kidney disease (CKD) patients.

Methods. A total of 197 patients were randomized to start subcutaneous epoetin-{alpha} (SC-EPO; EPREX®; 1000 U twice weekly) at an early stage of anaemia to maintain Hb at 11.0 ± 1.0 g/dl (group A, n = 65), or to allow Hb to fall to ≤9.0 g/dl before starting SC-EPO (group B, n = 132) (2000 U three times weekly); and subsequently maintaining Hb at 11.0 ± 1.0 g/dl.

Results. Of 132 patients randomized to group B, 55 progressed to treatment (-trigger). The study was prematurely terminated due to contraindication of the subcutaneous administration route. Mean weekly EPO doses at 1 year were 1471 U for group A; 820 U for group B; final doses were 2281 U for group A; 2099 U for group B. There was no significant difference between groups A and B with regard to left ventricular mass (-12.5 vs -9.7%; P = 0.82). In groups A and B, 48% and 52%, respectively, terminated the study because of dialysis/death, after a median of 36.3 and 27.3 months, respectively.

Conclusion. Early intervention to correct anaemia in CKD patients did not have a significant impact on LVM, the primary efficacy variable. Time to dialysis/death was not significantly different between groups A and B.

Keywords: anaemia; chronic kidney disease; early treatment; epoetin-{alpha}; pre-dialysis.
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[Abstract] [Full Text] [PDF]


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