NEW YORK Keryx Biopharmaceuticals has started a late-stage clinical trial of a drug for patients on kidney dialysis, the drug maker said Thursday.
Keryx plans to enroll around 150 people for a phase 3 trial of Zerenex (ferric citrate), a treatment for patients on kidney dialysis with elevated serum phosphorous levels, also known as hyperphosphatemia. The company started the short-term efficacy study Thursday and plans to start the long-term safety and efficacy study in third quarter 2010.
“I am pleased to be leading the registration program for Zerenex,” study chairwoman and Vanderbilt University medicine professor Julia Lewis said. “The clinical data generated to date suggests that Zerenex is an effective, safe and well-tolerated phosphate binder which we expect is differentiated form other marketed therapies by its iron composition and potential dosing convenience.”