This study investigated the effect of Procrit at a dose of 20,000 units administered once every two weeks, on hemoglobin response in patients with anemia related to chronic kidney disease 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, 88% of patients treated with Procrit 20,000 units achieved a target hemoglobin of between 11 and 12 grams per deciliter of blood. The mean hemoglobin 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 chronic kidney disease 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, chief, Division of Nephrology, Lankenau Hospital & Research Center in Wynnewood.
Procrit was well tolerated with most adverse events being mild to moderate and typical of patients with chronic kidney disease.
Ortho Biotech said that the findings suggest the need for well-controlled clinical trials to evaluate the efficacy and safety of extended initiation dosing regimens of Procrit for the treatment of chronic kidney disease anemia in patients not on dialysis.