STOCKHOLM—Hematide doses administered every four weeks (Q4W) maintains long-term mean hemoglobin levels between 11 and 12 g/dL in CKD patients, and it is well tolerated, according to preliminary data from an ongoing phase II trial.

The trial enrolled 84 patients. At baseline, their mean Hb level was 11.3 g/dL and their mean age was 60 years. Subjects received Hematide IV or subcutaneously Q4W. At 12 months, the mean Hb level was 12 g/dL. Iron stores were maintained throughout the study.

Serious adverse events (AEs) occurred in 13 patients (15.5%). Only four patients (4.8%) had at least one AE considered probably or possibly related to study drug, including increased or elevated potassium, arteriovenous fistula thrombosis, and hypertension.Hematide is a novel synthetic pegylated erythropoiesis stimulated agent.

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Findings were presented here at the 2008 congress of the European Renal Association-European Dialysis and Transplant Association.