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
