Authors: Spinowitz, Bruce S.¹; Pratt, Raymond D.²; The Epoetin Delta 2002 Study Group,

Source: Current Medical Research and Opinion, Volume 22, Number 12, December 2006 , pp. 2507-2513(7)

Publisher: Informa Healthcare

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 ≥ 11.5 g/dL for two consecutive weekly measurements or one haemoglobin measurement of ≥ 13 g/dL (correction success). A maintenance phase followed where the dose was adjusted to maintain haemoglobin ≥ 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.

Keywords: CHRONIC KIDNEY DISEASE; CLINICAL TRIAL; EPOETIN DELTA; ERYTHROPOIETIN; HAEMODIALYSIS; RANDOMIZED CONTROLLED TRIAL

Document Type: Case report

DOI: http://dx.doi.org/10.1185/030079906X158048

Affiliations: 1: Departments of Nephrology and Medicine, New York Hospital Queens and Cornell University Medical Center, New York, NY, USA 2: Shire plc, Wayne, PA, USA

Publication date: 2006-12-01

More about this publication?

• Information for Authors
• Subscribe to this Title
• Terms & Conditions
• General Information
• Journal Information
• ingentaconnect is not responsible for the content or availability of external websites

Related content

• In this: publication
• By this: publisher
• In this Subject: Medicine (General)
• By this author: Spinowitz, Bruce S. ;  Pratt, Raymond D. ;  The Epoetin Delta 2002 Study Group,

Website © Publishing Technology. Article copyright remains with the publisher, society or author(s) as specified within the article.

• Terms and conditions
• Privacy policy
• Information for advertisers