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June 10, 2013
Keryx Biopharmaceuticals reported results from a phase III trial of Zerenex for the treatment of elevated serum phosphorus levels in patients with end-stage renal disease (ESRD) on dialysis. This multicenter, randomized, open-label, safety and efficacy clinical trial enrolled 441 ESRD patients on hemodialysis or peritoneal dialysis. Zerenex was administered using a 1-gram oral caplet formulation. The study consisted of a two-week washout period followed by a 52-week Safety Assessment Period in which subjects were randomized 2:1 to receive either Zerenex or an active control (Renvela and/or Phoslo). The 52-week SAP was followed by a four-week Efficacy Assessment Period (EAP). Zerenex met the primary endpoint of effectively controlling serum phosphorus in the EAP. Safety results yielded a positive overall profile and results were well tolerated. The most frequent adverse events were infections and infestations, vascular disorders, gastrointestinal disorders and cardiac disorders.
November 1, 2010
Alexion issued positive interim results from two phase II trials of eculizumab for the treatment of atypical Hemolytic Uremic Syndrome. The first open label trial enrolled 17 adolescent and adult subjects who were resistant to plasma therapy. The subjects received eculizumab for up to 26 weeks. The primary endpoint of the study is the change in platelet count, a measure of thrombotic microangiopathy (TMA). Data showed a significant increase in platelet count with eculizumab treatment compared to baseline (p<0.0001). Key secondary clinical endpoints were also positive. The second open label trial enrolled 20 adolescent and adult subjects who were receiving plasma therapy chronically prior to entering the study. The primary endpoint was TMA Event-Free Status, as defined by stable platelet counts, absence of plasma therapy and no new dialysis. In this interim analysis of 15 subjects treated with eculizumab for at least 12 weeks, a significant 87% achieved the primary endpoint. Key secondary clinical endpoints were also positive. Eculizumab was well-tolerated, with the most common adverse events including anemia, diarrhea, headache, nausea and hypertension.