Phase 2 study of Zerenex for hyperphosphatemia in end-stage renal disease

Keryx Biopharmaceuticals announced results from the Phase 2 study of Zerenex (ferric citrate) for the treatment of hyperphosphatemia in patients with end-stage renal disease (ESRD) on thrice weekly hemodialysis. The study was a multicenter, open-label trial, which enrolled 55 ESRD patients. The primary objective of the study was to assess the tolerability and safety of Zerenex with doses ranging from approximately 1–12g/day. In the study, patients who were taking calcium acetate, calcium carbonate, lanthanum carbonate, sevelamer HCl, or any combination of these agents, were switched to Zerenex. Patients were treated for four weeks and were titrated weekly to achieve and maintain serum phosphorous levels between 3.5–5.5mg/dL. In the subset of patients who had a serum phosphorous >5.5mg/dL immediately prior to the switch to Zenerex, the mean serum phosphorous at baseline was 7.0mg/dL and at the end of treatment was 5.6mg/dL.

Zerenex is an oral, iron-based compound that has the capacity to bind to phosphate and form non-absorbable complexes.

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