Genzyme Corp. 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 (sevelamer hydrochloride). The multi-centre, single arm, open-label trial involved 49 patients at multiple study sites throughout Europe and Australia.
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 represent one portion of a comprehensive clinical programme 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, enrolment 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.