Genzyme has announced that a recently completed study of Renvela (sevelamer carbonate) achieved its primary endpoint, demonstrating a statistically significant reduction in serum phosphorus for hyperphosphatemic patients with chronic kidney disease who are not on dialysis.
Patients treated with Renvela also achieved a significant reduction in calcium-phosphorus product and in LDL cholesterol. The drug was well tolerated with a safety profile consistent with the clinical experience of patients on dialysis using Renagel(R) (sevelamer hydrochloride). The multi-center, single arm, open-label trial involved 49 patients at multiple study sites throughout Europe and Australia.
Full data will be presented at a future medical conference.
Renvela is a buffered form of Renagel, the most-prescribed phosphate binder in the United States. Like Renagel, Renvela is a calcium-free, metal- free, non-absorbed phosphate binder and will initially be available as 800mg tablets once approved.
The results announced today represent one portion of a comprehensive clinical program for sevelamer carbonate. Data showing the equivalence of sevelamer carbonate and sevelamer hydrochloride were presented last week at the spring clinical meeting of the National Kidney Foundation. In addition, enrollment is complete in two studies comparing a powder form of sevelamer carbonate to Renagel tablets dosed three times per day, including one study in which the powder form is dosed three times per day, and one in which it is dosed once per day.
A New Drug Application for Renvela is currently under review by the US Food and Drug Administration for the control of serum phosphorus in patients with chronic kidney disease on dialysis.
Renagel controls serum phosphorus in patients with CKD 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 percent).
The 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.