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Title: Renagel in New Dialysis Study Published in Kidney International

"Renagel in New Dialysis Study Published in Kidney International"

Data Show That Patients Treated with Renagel Achieve Mortality Benefits MISSAUGA, ON, CANADA -- January 15, 2007 -- Genzyme Canada announced today that findings published in the online version of Kidney International demonstrate that patients using Renagel experienced a significantly lower rate of death compared with patients using calcium-based phosphate binders in a newly completed study. The results were drawn from the Renagel in New Dialysis study (RIND), a randomized open-label trial involving 127 patients new to hemodialysis at five dialysis centers in the United States. All-cause mortality was a pre-specified secondary endpoint. Results of the primary endpoint -- a comparison of the degree of coronary artery calcification after 18 months of treatment -- were published last year and also showed a statistically significant result in favor of the Renagel-treated population. According to the study design, patients new to hemodialysis were randomized to receive either Renagel or a calcium-based phosphate binder, and were followed for an average of 44 months of treatment. Over the treatment period, 34 deaths occurred among study participants, including 23 patients who were using calcium-based binders and 11 who were using Renagel. The difference between the two groups was statistically significant (P =.05). After adjustments were made for a range of factors, including age, race, gender and several baseline medical characteristics, the difference between the two groups was even greater (P =.016). "These results are significant because they show for the first time that higher levels of coronary artery calcification are associated with a higher incidence of death in patients on dialysis," said principal investigator Geoffrey Block, MD, of Denver Nephrologists, PC, Denver, Colorado. "Given the high mortality rate seen in patients on dialysis, control of coronary artery calcification should be an important consideration for health professionals when determining the type of therapy that is appropriate for their patients." "It would seem that by using incident as opposed to prevalent patient groups as has been done in a previous study, this one was able to reveal superior outcomes", said David Mendelssohn, MD, FRCPC from the Department of Nephrology at Humber River Regional Hospital and University of Toronto. "The RIND study supports the arguments about the importance of treating dialysis patients with non calcium-based phosphate binders, such as Renagel, in the early stages of disease development as a means of prolonging life". Today's findings build on previously published data by establishing a link between choice of phosphate binders, calcification levels, and mortality. Earlier results from the RIND study showed that while each type of phosphate binder helped patients achieve the target levels for phosphorus and calcium-phosphorus product outlined in the 2003 National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (K/DOQI) guidelines, patients using calcium-based phosphate binders experienced more rapid and more severe progression of coronary artery calcification than those using Renagel. The Renagel in New Dialysis study was funded by Genzyme Corporation. About Renagel Renagel controls serum phosphorus in patients with chronic kidney disease on hemodialysis. Controlling serum phosphorus is an important element in the care of hemodialysis patients. Elevated serum phosphorus levels are common in dialysis patients and associated with increased risk of cardiovascular mortality. Renagel provides the added benefit of significant LDL cholesterol reduction (32%). The US-based National Kidney Foundation's 2003 K/DOQI guidelines for Bone Metabolism and Disease in Chronic Kidney Disease recommend sevelamer hydrochloride as a first line treatment option to control phosphorus. Renagel is the only phosphate binder available that does not contain either calcium or a metal. It has an established safety profile, is not systemically absorbed and provides phosphorus control without the concerns of calcium or metal accumulation. Renagel is used by more than 350,000 people worldwide. SOURCE: Genzyme

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