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The study was a multicenter, open-label clinical trial, which enrolled 55 patients. The primary objective of this study was to assess the tolerability and safety of Zerenex (ferric citrate) with doses ranging from approximately 1gm per day to 12gm per day.
In the first part of the Phase II study, 34 end-stage renal disease (ESRD) patients who were taking approximately six to 15 tablets/capsules per day of calcium acetate, calcium carbonate, lanthanum carbonate or sevelamer hydrochloride or any combination of these agents were eligible for enrollment and immediately switched to a starting dose of 4.5gm per day of Zerenex.
In the second part of the study, 21 ESRD patients who were taking more than 12 tablets/capsules per day of calcium acetate, calcium carbonate, lanthanum carbonate or sevelamer hydrochloride or any combination of these agents were eligible for enrollment and immediately switched to a starting dose of 6gm per day of Zerenex. Patients were treated with Zerenex for four weeks and were titrated weekly to achieve and maintain normal serum phosphorus levels, between 3.5 to 5.5mg/dl, the therapeutic goal. Although designed primarily as a safety study, key efficacy parameters were evaluated.
According to Keryx, the results showed that baseline mean plus or minus standard deviation (SD) serum phosphorus was approximately 5.9 plus or minus 1.5mg/dl immediately prior to the switch to Zerenex; the average daily dose of PhosLo was 6.9gm per day and for Renagel was 9.9gm per day, for patients not on combination therapy prior to the switch to Zerenex.
At the end of the treatment period the mean plus or minus SD serum phosphorus was approximately 5.4 plus or minus 1.3mg/dl; The average daily dose of Zerenex at the end of four weeks of treatment was 6.8gm per day.
The FDA indicated that the results of the Phase II study and the toxicology studies were adequate to support entry into a Phase III program. Keryx is in the process of finalizing the Phase III program in consultation with the FDA.
Ron Bentsur, CEO of Keryx, said: "The promising safety and efficacy profile of Zerenex indicates that there is significant market potential for the drug in the phosphate binder space. We're excited to have two late stage clinical drug candidates, Zerenex and KRX-0401, both with compelling Phase II data."
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