July 24 A pivotal trial of Keryx
Biopharmaceuticals Inc's experimental drug Zerenex
showed that it improved levels of serum phosphorus and iron in
patients on kidney dialysis, according to results published on
The trial involved 441 patients, according to the Journal of
the American Society of Nephrology, which published the results.
Over the four-week efficacy assessment period, mean serum
phosphorus for Zerenex patients dropped by 2.2 milligrams per
deciliter compared with placebo patients, the trial showed.
Most patients with kidney disease that requires dialysis
need chronic treatment with phosphate-binding agents to lower
and maintain serum phosphorus at acceptable levels.
The study found that, if approved, Zerenex would be the only
phosphate binder that also increases iron stores, reducing the
need for other drugs to treat anemia.
Side effects experienced by patients treated with Zerenex
included diarrhea, nausea, vomiting and constipation. Serious
adverse events were reported in 39.1 percent of the Zerenex
patients and 49 percent of patients in the control group.
The U.S. Food and Drug Administration, which earlier this
year cited manufacturing information as the reason for a
three-month extension of its review of Zerenex, is expected to
decide by Sept. 7 whether to approve the drug.
(Reporting by Deena Beasley; Editing by Jan Paschal)