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Newly Published Study Evaluates Extended Dosing Regimens of PROCRIT(R) (Epoetin Alfa) As Maintenance Treatment for Patients With Anemia From Chronic Kidney Disease

Posted on: Thursday, 11 August 2005, 12:00 CDT

BRIDGEWATER, N.J., Aug. 11 /PRNewswire/ -- A new study published in the August 2005 issue of Clinical Nephrology suggests that less frequent dosing of PROCRIT(R) (Epoetin alfa) may result in a similar response to that of weekly dosing for maintaining hemoglobin -- or red blood cell -- levels in patients with anemia related to chronic kidney disease who are not on dialysis. More than 20 million Americans -- or one in nine adults -- are estimated to have chronic kidney disease, and as many as two-thirds of these patients develop anemia.

A total of 519 patients with anemia related to chronic kidney disease not on dialysis were enrolled in the open-label study, Clinical Evaluation of PROCRIT(R) for Maintenance Phase Treatment of Patients with Anemia due to Chronic Kidney Disease, referred to as the PROMPT study. The study found that approximately 90 percent of patients dosed with PROCRIT(R) once every two weeks and more than 75 percent of patients dosed once every three or four weeks maintained hemoglobin levels greater than or equal to 11 grams per deciliter of blood.

The product labeling for PROCRIT(R) recommends a target hemoglobin range of between 10 and 12 grams per deciliter of blood. Maintenance of hemoglobin at these levels is consistent with the Kidney Disease Outcomes Quality Initiative guidelines, published in 2001 by the National Kidney Foundation.

Patients enrolled in the PROMPT study were randomized to receive one of four PROCRIT(R) dosing schedules: 10,000 units once weekly, 20,000 units every two weeks, 30,000 units every three weeks or 40,000 units every four weeks. The dosages used in this study are not FDA approved. The current FDA-approved dose for adult patients with anemia related to chronic kidney disease who are not on dialysis is 50 to 100 units per kilogram of body weight three times per week.

"The results of the PROMPT study suggest that PROCRIT(R) may provide sufficient hemoglobin levels in patients even when dosed less than once weekly for maintenance therapy," said the study's principal investigator, Robert Provenzano, MD, FACP, Division of Nephrology, St. John Hospital and Medical Center in Detroit, Michigan. "Since PROCRIT(R) is most often administered by doctors or nurses, this finding could ultimately provide patients with anemia related to chronic kidney disease increased convenience and flexibility when planning their doctor visits."

The PROMPT study was designed to determine whether extended PROCRIT(R) dosing schedules of up to once every four weeks are comparable to weekly dosing in maintaining hemoglobin levels in patients with anemia related to chronic kidney disease who are not on dialysis. The primary endpoint for the trial was the average final hemoglobin levels for patients dosed weekly, once every two weeks, once every three weeks and once every four weeks. Results were analyzed through non-inferiority assessments of the average final hemoglobin levels of the groups on extended dosing schedules compared to the group receiving weekly dosing. Patients were required to have a stable hemoglobin level greater than or equal to 11 grams per deciliter of blood and to have been previously receiving Epoetin alfa for two or more months. Dose reductions were made over the course of the study, but increases were not permitted. Patients received treatment for a total of 16 weeks.

Throughout the course of the study, 93.5 percent, 89.5 percent, 77.2 percent and 76 percent of patients maintained hemoglobin levels greater than or equal to 11 grams per deciliter of blood in the weekly, once every two weeks, once every three weeks and once every four weeks groups, respectively. The results for the groups dosed once every two weeks and once every four weeks were statistically non-inferior to the group dosed weekly.

The incidence of adverse events was comparable across all study groups. The most common adverse events in any treatment group were hypertension or high blood pressure, 6.8%; peripheral edema or swelling of the feet, 5.7%; urinary tract infection, 4.3%; and headache, 3.3%. Across all study groups, 16 or 3.1% of patients withdrew from the study due to adverse events.

Ortho Biotech Products, L.P., the marketer of PROCRIT(R), supported the study. Dr. Robert Provenzano, principal investigator of the study, is a consultant to Ortho Biotech Products, L.P.

About Chronic Kidney Disease

Chronic kidney disease is a progressive condition in which the kidneys are unable to function effectively. More than 20 million Americans -- or one in nine adults -- are estimated to have this condition, and as many as two-thirds of them develop anemia. As the kidneys' ability to function decreases, they become unable to help the body produce red blood cells, which contain oxygen-carrying hemoglobin, resulting in anemia. Hemoglobin is the main measure doctors use to assess the severity of anemia. Symptoms of anemia include tiredness, dizziness and shortness of breath. PROCRIT(R) helps treat anemia by increasing the number of red blood cells in the body.

About PROCRIT(R) (Epoetin alfa)

PROCRIT(R) (Epoetin alfa) is a prescription medication for the treatment of anemia in chronic kidney disease patients who are not on dialysis and is injected by doctors or nurses.

PROCRIT(R) is not for patients with uncontrolled high blood pressure. High blood pressure has been noted in patients treated with PROCRIT(R) and blood pressure should be monitored carefully. Drugs like PROCRIT(R) may increase the risk of blood clots and seizures. Loss of response to PROCRIT(R) could be a sign of a very rare but serious condition. In studies, the most common side effects were high blood pressure, headache, joint pain and nausea.

For full U.S. Prescribing Information and additional information on PROCRIT(R), please refer to the accompanying package insert or visit http://www.procrit.com/.

About Ortho Biotech Products, L.P.

In 1990, Ortho Biotech Products, L.P. was established in Raritan, N.J. Since that time, Ortho Biotech and its worldwide affiliates have earned a global reputation for researching, manufacturing and marketing innovative products that enhance patients' health. Ortho Biotech, located in Bridgewater, N.J., is an established market leader in Epoetin alfa therapy for anemia management across multiple indications and focuses its research and marketing efforts in four clinical areas: oncology, nephrology, immunology and surgery.

Ortho Biotech, in partnership with leading patient and professional organizations, introduced http://www.kidneyresource.com/ this year. It is the first-ever comprehensive directory of chronic kidney disease sites on the World Wide Web. This site provides physicians, patients and caregivers immediate access to more than 60 Web sites, many of which are operated by non-profit, educational and patient advocacy organizations. The site also offers an interactive anemia awareness center, which features information about anemia related to chronic kidney disease.

Ortho Biotech Products, L.P.

CONTACT: Stephanie Fagan of Ortho Biotech Products, L.P.,+1-908-541-4029 (office), +1-201-572-9581 (cell), sfaganoe@gpcus.jnj.com, orLeanne Madison of Ogilvy Public Relations Worldwide for Ortho BiotechProducts, L.P., +1-212-880-5246 (office), +1-857-205-8415 (cell),leanne.madison@ogilvypr.com

Web site: http://www.procrit.com/http://www.kidneyresource.com/

Source: PRNewswire

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