CAMBRIDGE, Mass.—Genzyme Corp. said today that it has completed a study of Renvela (sevelamer carbonate), which showed a statistically significant reduction of serum phosphorus for hyperphosphatemic patients in chronic kidney disease patients not on dialysis.
Patients in the Renvela study also had a significant reduction in calcium-phosphorus product and in LDL cholesterol, according to Genzyme. The multi-center, single arm, open-label trial included 49 patients as multiple sites in Europe and Australia.
Renvela is a buffered form of Renagel and is intended to control serum phosphorus levels in dialysis patients. Genzyme said Renvela is being developed to replace its existing phosphate binder Renagel. The biopharmaceutical company added that Renvela is a non-calcium, non-metal, non-absorbed phosphate binder that will be available in 800 mg tablets once it is approved.
Genzyme Corp. filed a New Drug Application in March with the U.S. Food and Drug Administration for Renvela to be used in chronic kidney disease patients on dialysis.
Genzyme said Renvela was well tolerated with a safety profile consistent with the clinical experience if patients on dialysis using Renagel. Data for the trial will be presented at a future medical conference, said Genzyme. Data was presented at last week’s National Kidney Foundation meeting that showed equivalence between Renvela and Renagel.
Researchers have also completed enrollment in two studies to compare a powder form of Renvela to Renagel tablets.
Email this article
Add a comment
Printer version
Order reprints
RSS Feed
Bookmark article