Patients Achieved Target Hemoglobin Range With PROCRIT
Posted by brinkman on December 9, 2006
Today, at the American Society of Nephrology’s 39th Annual Meeting and Scientific Exposition, data was presented for the first time on the initiation of PROCRIT® (Epoetin alfa) therapy 20,000 Units once every two weeks in patients with anemia related to chronic kidney disease (CKD) who are not on dialysis. The FDA-approved initiation dose of PROCRIT® for this patient population is 50-100 Units/kg three times per week.
In the study, the majority (>88 percent) of patients treated with PROCRIT® 20,000 Units once every two weeks achieved a target hemoglobin (Hb) of between 11 and 12 grams per deciliter of blood (g/dL). The mean Hb reached the target range by week six and stayed in that range for the remainder of the 28-week study.
“These results suggest that anemic CKD patients not on dialysis may be administered PROCRIT® less frequently at an initiation dose of 20,000 Units once every two weeks,” explained the study’s principal investigator, Robert Benz, MD, Chief, Division of Nephrology, Lankenau Hospital & Research Center in Wynnewood, PA.
Study Design
This prospective, open-label, single-arm, multi-center study investigated the effect of PROCRIT® 20,000 Units administered once every two weeks on hemoglobin response. The primary endpoint of the study was the percentage of patients who achieved and maintained a hemoglobin level between 11 and 12 grams per deciliter of blood for at least two consecutive weeks by study week 28. The product labeling for PROCRIT® recommends a target hemoglobin range between 10 and 12 grams per deciliter of blood.
The study included 67 patients with chronic kidney disease not on dialysis who had a baseline Hb level of
