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Phase 4 Trial Investigates PhosLo-Lipitor Combination in Patients With End-Stage Renal Disease
ROCKVILLE, Md., June 10 /PRNewswire-FirstCall/ -- As part of its clinical strategy to expand PhosLo's growing presence in the global marketplace, Nabi Biopharmaceuticals has initiated its PRECISE trial. The trial is a Phase IV clinical study evaluating PhosLo® (calcium acetate), the company's prescription phosphate binder product used to control elevated phosphorus levels (hyperphosphatemia) in patients with end-stage renal (kidney) disease or ESRD, with the statin Lipitor (atorvastatin calcium) in approximately 150 patients. The trial is designed to demonstrate the significance of using PhosLo plus Lipitor as a combination therapy to optimize cardiovascular health in ESRD patients.
Cardiac illness is a major contributor to deaths in ESRD patients. Current and emerging clinical data support the following three factors as important to improving their cardiac health: the level of phosphate in their blood, the calcium-phosphate balance, measured by the product of serum phosphate and serum calcium levels, and cholesterol levels. The PRECISE trial has been designed to provide physicians with important new data on the combination of PhosLo plus a statin in treating these patients. In addition, the study is expected to demonstrate that cost of this combination therapy will still be significantly lower than the cost of treatment with the other prescription phosphate binder currently available on the U.S. market.
"Cardiac risk factors are an extremely important consideration in the management of ESRD patients on hemodialysis, as cardiovascular disease is responsible for more than 50% of all deaths in this patient population. We believe the results of the PRECISE trial will show that PhosLo's effective control of hyperphosphatemia combined with the reduction of cholesterol levels in this patient population can confer a significant benefit by reducing the risk of developing cardiovascular complications. Consequently, we believe treatment that lipid-lowering agents such as statins will become the standard of care for ESRD patients. The PRECISE trial will specifically evaluate the combination of PhosLo and Lipitor to define the optimal treatment regimen for this patient population," said Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and regulatory affairs, Nabi Biopharmaceuticals.
"Nabi has already demonstrated that PhosLo is a superior regulator of serum phosphorus levels and the calcium-phosphorus product from the results of a well-designed clinical trial recently published in Kidney International (CARE Study, May 2004; Volume 65, Issue 5). Nabi also demonstrated that PhosLo achieved this important goal in the treatment of hyperphosphatemia while maintaining a significant cost advantage compared to other prescription treatments for this condition in the U.S. In addition, there is a growing body of evidence, including the recent data presented at the American Diabetes Association, that states use of a statin, even in patients with normal cholesterol levels, can provide significant medical benefits."
About the PRECISE Trial
The PRECISE trial is a double-blinded, placebo-controlled study that will randomize ESRD patients to receive PhosLo plus Lipitor, or PhosLo plus a placebo. A total of approximately 150 patients will be enrolled in the study that will involve approximately 15 study sites. The primary endpoint in the study will be the measurement of cardiovascular calcification by Electron Beam Computer Tomography (EBCT), an accepted analytical measurement tool for the assessment and quantification of cardiovascular calcification. Secondary endpoints in the study will include serum phosphate, calcium-phosphate product, lipid levels and how well the combination of these products was tolerated by patients. Patient enrollment is expected to take approximately 6 months and patients will be followed in this study for 12 months. Preliminary data regarding effect on serum phosphorus, calcium-phosphorus product and serum lipid levels may be presented by the end of 2004; the cardiovascular calcification data is expected to be available by the end of 2005.
Thomas H. McLain, chairman, chief executive officer and president of Nabi Biopharmaceuticals, stated, "Data from this trial will be very important toward our goal of providing nephrologists and treatment teams with important information that can allow them to optimize outcomes for these patients." Mr. McLain continued, "This trial, which is closely aligned with emerging standards of care for ESRD patients, will demonstrate the medical and economic advantages of using PhosLo with a statin. In turn, we believe the outcome of this trial will reinforce PhosLo's importance as a first-line therapy for the treatment of hyperphosphatemia, thereby greatly increasing market penetration both in the U.S. and in our target ex-U.S. markets."
About Nabi's PhosLo
Nabi Biopharmaceuticals' PhosLo is a prescription phosphate binder indicated for the control of elevated phosphorus levels (hyperphosphatemia) in patients with chronic kidney disease and renal failure. The largest segment addressed by this product are end-stage renal (kidney) disease (ESRD) patients undergoing maintenance renal dialysis. According to the U.S. Renal Data System, there were approximately 275,000 Americans who met the criteria for chronic renal dialysis in 2000 and this population is projected to increase to 520,000 by the end of the decade. This strong growth is being driven by dramatic increases in the diabetic patient population (diabetes is the most common cause of ESRD), general aging of the population and a slowing in the death rate for dialysis patients.
PhosLo is distinct from calcium carbonate products, typically over-the- counter products such as TUMS® in the U.S. or prescription calcium carbonate products in Europe. It does not appear that calcium carbonate products meet the K/DOQI guidelines due to the comparatively lower phosphate binding activity of calcium carbonate. As a result of this reduced activity, calcium carbonate products would be expected to result in calcium loads well in excess of K/DOQI guidelines for non-dietary calcium absorption.
PhosLo is administered orally, and when given with food, it combines with dietary phosphate to form insoluble calcium-phosphate complexes that are eliminated from the body, thereby reducing phosphorus absorption, helping to prevent excess blood phosphorus levels. Patients should have serum calcium levels closely monitored and their dose of PhosLo adjusted or terminated to bring levels to normal. PhosLo is contraindicated in patients with hypercalcemia. No other calcium supplements should be given concurrently with PhosLo.
Source: Nabi Biopharmaceuticals