www.fdanews.com/articles/100699-shire-provides-results-of-fosrenol-study
Shire Provides Results of Fosrenol Study
November 6, 2007
In a Phase II study, Shire’s Fosrenol, a noncalcium phosphate binder indicated to treat hyperphosphatemia in end stage renal disease, reduced serum phosphate levels in chronic kidney disease (CKD) patients not on dialysis.
While the 90-patient, multicenter, double-blind, placebo-controlled study did not achieve its specified primary endpoint of controlling serum phosphate to within normal levels, more Fosrenol-treated patients achieved this goal than patients in the placebo arm, Shire said.
As a secondary endpoint, patients taking Fosrenol were found to have statistically significant reductions in serum phosphate levels after eight weeks of treatment versus those in the placebo arm.