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Curr Med Res Opin. 2006 Dec;22(12):2507-13.

Epoetin delta is effective for the management of anaemia associated with chronic kidney disease.

Author information

1
Department of Nephrology, New York Hospital Queens and Cornell University Medical Center, New York, NY, USA.

Abstract

OBJECTIVE:

To demonstrate the efficacy and safety of epoetin delta for the treatment of anaemia in dialysis patients with chronic kidney disease (CKD).

RESEARCH DESIGN AND METHODS:

This was a 12-week, randomized, double-blind, active-comparator study. CKD patients who were naïve to epoetin treatment and had haemoglobin < 10 g/dL were randomized to epoetin delta 15, 50, 150, or 300 IU/kg or epoetin alfa 50 IU/kg. Patients initially entered a correction phase until they recorded haemoglobin of > or = 11.5 g/dL for two consecutive weekly measurements or one haemoglobin measurement of > or = 13 g/dL (correction success). A maintenance phase followed where the dose was adjusted to maintain haemoglobin > or = 10.5 g/dL. Maintenance success was defined as haemoglobin > 10.5 g/dL at Week 12. Total success was defined as achieving maintenance and correction success.

MAIN OUTCOME MEASURES:

The primary objective was to demonstrate that the proportion of patients achieving total success was greater in the pooled 150 IU/kg and 300 IU/kg groups compared with the 15 IU/kg dose group.

RESULTS:

Total success was achieved in 55.6% of patients in the pooled highest epoetin delta group compared with 4.5% in the lowest dose group. There was no significant difference in total success for the epoetin delta and epoetin alfa 50 IU/kg groups. Significant increases in haemoglobin and haematocrit levels were observed in the 150 and 300 IU/kg dose groups. Adverse events occurred at frequencies expected for this patient group.

CONCLUSIONS:

Epoetin delta was effective in increasing haemoglobin levels in patients with baseline haemoglobin of < 10 g/dL.

PMID:
17166333
DOI:
10.1185/030079906X158048
[Indexed for MEDLINE]

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