CHICAGO, April 20 /PRNewswire/ -- Final data from an investigational clinical trial, Correction of Hemoglobin and Outcomes in Renal Insufficiency, referred to as the CHOIR study, were presented today at the National Kidney Foundation (NKF) 2006 Spring Clinical Meetings. The study was conducted to understand whether anemic patients with chronic kidney disease not on dialysis, treated with PROCRIT(R) (Epoetin alfa) to an investigational target hemoglobin level of 13.5 grams per deciliter of blood (g/dL), had improved mortality and specific cardiovascular outcomes compared to patients treated to a target hemoglobin level of 11.3 g/dL.
The primary analysis of the composite endpoint showed a statistically significant higher incidence of composite endpoint events -- consisting of mortality, stroke, heart attack and hospitalization due to congestive heart failure -- in the group of patients treated to the investigational hemoglobin target of 13.5 g/dL, as compared to the group treated to the hemoglobin target that is consistent with the current product label, 11.3 g/dL.
The approved labeling for PROCRIT(R) recommends target hemoglobin levels of 10 to 12 g/dL in anemic patients with chronic kidney disease not on dialysis. The 2000 National Kidney Foundation guidelines recommend patients be treated to a target hemoglobin level of 11 to 12 g/dL. "The results of this study reinforce the direction not to exceed the recommended target hemoglobin of 12 g/dL in anemic patients with chronic kidney disease," said Ajay Singh, M.D., a principal investigator of the study, and clinical chief, Renal Division, Brigham and Women's Hospital, Boston, MA, and associate professor, Harvard Medical School.
When used according to product labeling, PROCRIT(R) is a safe and effective treatment for the management of anemia in patients with chronic kidney disease not on dialysis.
A total of 1,432 patients in 130 U.S. sites were enrolled in the study. The primary endpoint was a composite endpoint. The composite endpoint was a combination of mortality and cardiovascular outcomes: stroke, heart attack and hospitalization due to congestive heart failure. Two hundred and twenty- two composite endpoint events occurred in the study up to its termination: 125 events in the 13.5 g/dL arm and 97 events in the 11.3 g/dL arm. The difference in the number of composite endpoint events was statistically significant. One hundred and twenty-eight patients died during the study and the 90-day study follow-up period: 72 patients in the arm being treated to 13.5 g/dL and 56 patients in the arm being treated to 11.3 g/dL. However, the difference in the number of patients who died between the two treatment arms was not statistically significant. The study investigators did not report an association between the reported deaths and the use of PROCRIT(R). The study was terminated in May 2005 upon recommendation of its data safety monitoring board. Results of the study have been reported to regulatory authorities.
Ortho Biotech Clinical Affairs, L.L.C. sponsored the study. Ajay Singh, M.D., clinical chief, Renal Division, Brigham and Women's Hospital, Boston, MA, and associate professor of Harvard Medical School and Donal Reddan, M.D., consultant nephrologist, University College, Galway, Ireland, and adjunct assistant professor, Duke University, are principal investigators for the study. Duke Clinical Research Institute was the contract research organization.
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) is for the treatment of anemia in chronic kidney disease patients who are not on dialysis. PROCRIT(R) is available by prescription only and is injected by a doctor or nurse. PROCRIT(R) has been prescribed for more than 10 years to treat anemia in patients with chronic kidney disease not on dialysis.
Important Safety Information
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.
Please visit http://www.procrit.com for important product information.
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.