Hematide maintains stable hemoglobin levels long term in chronic renal failure patients, study says.
GRAPEVINE, TEX.—Once monthly administration of Hematide, a novel erythropoiesis stimulating agent (ESA), maintains stable hemoglobin (Hb) levels of 11-12 g/dL and is safe and well tolerated long term, according to data presented here at the National Kidney Foundation 2008 Spring Clinical Meetings.
The data come from a phase II follow-up study of 81 hemodialysis patients who received IV Hematide every four weeks for 18 months, including an initial six-month trial in which the patients were switched to Hematide from epoetin alfa and then another 12 months of Hematide treatment. Hematide is a pegylated peptidic compound that binds to and inactivates the erythropoietin receptor.
At 18 months, the patients had a mean Hb value of 11.3 g/dL, according to a research team led by Robert Geronemus, MD, medical director of South Florida Research Institute in Lauderdale Lakes, Fla. Their mean ferritin level was about 80 ng/mL and mean transferrin saturation value was about 45%, measurements that meet guidelines established by the NKF’s Kidney Disease Outcomes Quality Initiative.
Adverse events occurred in 76 patients (93.8%).The most frequent AEs included upper respiratory tract infection (27.2%), iron deficiency (19.8%), diarrhea (17.3%), and nausea (17.3%). Serious AEs occurred in 34 patients (42%).
The most frequent included congestive heart failure (7.4%) and gangrene (4%). None of the serious AEs were considered related to Hematide. Nine patients required transfusions of blood or blood products, an incidence of transfusion that is in line with clinical studies of CKD patients receiving other ESAs, the investigators stated.