Shire’s drug effective against chronic kidney disease

While the results of this exploratory study did not achieve its specified primary endpoint (control of serum phosphate to within normal levels), more Fosrenol treated patients achieved this goal than did patients in the placebo arm of this multi-center, double-blind, placebo-controlled study of 90 pre-dialysis patients with chronic kidney disease (CKD) stage 3 and 4 and hyperphosphatemia (serum phosphate above the upper limit of normal, which the body cannot excrete).

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 patients in the placebo arm.

The Phase II study involved the initial screening of 281 CKD stage 3 and
4 patients with 90 randomized to receive either Fosrenol or placebo.

Shire is working closely with the FDA to explore the regulatory pathway
forward for phosphate binding medicines in pre-dialysis patients with CKD
stage 4.

Raymond Pratt, vice president and scientific leader for the renal business unit of Shire Pharmaceuticals, said: “This study provides valuable insights into the evolution of kidney disease and the development of the hyperphosphatemic state in patients with CKD. There is a paucity of data in this population and this study marks an important step toward learning more about the management of this patient population – and importantly, shows that a little bit of kidney function still goes a long way to maintain phosphate balance.”