%0 Journal Article
%T Comparison of different dosing regimens (once weekly vs. twice weekly, and once weekly vs. once every two weeks) with epoetin delta in patients with chronic kidney disease: a randomized controlled trial
%A Iain C Macdougall
%J Trials
%D 2007
%I BioMed Central
%R 10.1186/1745-6215-8-35
%X This is a randomized, open-label, multicentre trial. Patients aged 18 years or above with chronic kidney disease (Stages 3¨C5) are eligible to enter this trial. Two groups of patients form the trial population, those na£¿ve to ESA therapy and those previously stable on ESA therapy. There are two primary objectives of this trial: 1) to demonstrate non-inferiority between twice weekly and once weekly dosing of epoetin delta in previously na£¿ve patients (assessed by haemoglobin at Week 24); 2) to demonstrate non-inferiority between once weekly and once every two weeks dosing in previously stable patients (assessed by average haemoglobin over Weeks 16¨C24). Among the secondary analyses will be assessments of haematocrit, number(%) of patients meeting predefined targets for haemoglobin and haematocrit levels, and comparisons of average dose. All patients will receive study medication for 24 weeks and dose will be adjusted according to a predefined algorithm to achieve and maintain haemoglobin ¡Ý 11 g/dL. All patients completing this trial are eligible to enter a 2-year follow-up study to enable monitoring of emergent adverse events, anti-erythropoietin antibody responses, maintenance of efficacy and changes in diabetic retinopathy status.To our knowledge, this trial is the first to randomize ESA-na£¿ve patients to different dosing regimens of the same ESA. Data generated will help in guiding the most appropriate dosing frequency for epoetin delta, particularly in those patients new to epoetin delta therapy.ClinicalTrials.gov: NCT00450333Chronic kidney disease (CKD) is a growing problem, particularly in the Western world [1] and anaemia is a common complication of CKD, with up to half of all patients affected [2]. Diabetes is the leading cause of CKD in the Western world and in diabetic CKD patients anaemia often develops earlier and more severely than in non-diabetic patients with similar renal function [3,4]. As kidney function declines the prevalence of renal anaemia increa
%U http://www.trialsjournal.com/content/8/1/35