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Keryx Biopharmaceuticals Reports Positive Phase 2 Study Results of Zerenex (Ferric Citrate) for the Treatment of Hyperphosphatemia in End-Stage Renal Disease Patients
Date:6/8/2009

y combination of these agents were eligible for enrollment and immediately switched to a starting dose of 6.0 grams per day of Zerenex (ferric citrate). Patients were treated with Zerenex (ferric citrate) for four weeks and were titrated weekly to achieve and maintain normal serum phosphorus levels, between 3.5 to 5.5 mg/dL, the therapeutic goal.

Although designed primarily as a safety study, key efficacy parameters were evaluated, with results as follows:

At baseline:

  • Baseline mean + standard deviation (SD) serum phosphorus was approximately 5.9 + 1.5 mg/dL immediately prior to the switch to Zerenex (ferric citrate);
  • The average daily dose of PhosLo(R) (calcium acetate) was 6.9 grams per day and for Renagel(R) (sevelamer hydrochloride) was 9.9 grams per day, for patients not on combination therapy prior to the switch to Zerenex (ferric citrate).

Following the treatment period (four weeks on Zerenex):

  • At the end of the treatment period (after four weeks on Zerenex) the mean + SD serum phosphorus was approximately 5.4 + 1.3 mg/dL;
  • The average daily dose of Zerenex (ferric citrate) at the end of four weeks of treatment was 6.8 grams per day.

In the subset of patients who had a serum phosphorus above the normal range (> 5.5 mg/dL) immediately prior to the switch to Zerenex (n = 29), the mean (SD) baseline serum phosphorus was 7.0 (1.1) mg/dL, and at the end of treatment with Zerenex the mean (SD) serum phosphorus was 5.6 (1.6) mg/dL.

In the Phase 2 study, there were four serious adverse events which were deemed unrelated to Zerenex. Darkened stool was reported in the study and was associated with the presence of iron in the gastrointestinal tract. With the exception of the reporting of darkened stool
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SOURCE Keryx Biopharmaceuticals, Inc.
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