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Keryx (KERX) Plans to Present Detailed Phase 3 Data at Fourth Quarter Medical Conference on Auryxia in Treatment of Iron Deficiency Anemia in Adults With Non-Dialysis Dependent Chronic Kidney Disease

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Clinical Data Update on Nov 18 2016: About the Case Study Retrospective DataData from a retrospective chart review of 92 patients were collected by seven health care providers at multiple clinics across the U.S. Patients with CKD on dialysis who had been taking Auryxia for the control of serum phosphorus for a minimum of six months were selected to participate. The retrospective data demonstrate Auryxia’s effect in dialysis-dependent chronic kidney disease patients in routine clinical practice.Of the 92 patient charts, 25 people were receiving peritoneal dialysis and 62 people were receiving in-center hemodialysis as part of routine clinical care. At the time of Auryxia treatment initiation, 21 patients (23%) were naïve to phosphate binders, while the remaining were treated with sevelamer (n = 37, 52%), calcium-based binders (n = 20, 28%), sevelamer + calcium (n = 10, 14%), or another binder (n = 4, 6%). Data collected included patients who took Auryxia for at least six months.Case Study Data:
Target phosphate level: 22 percent of patients were within the KDOQI guidelines range of 3.5 mg/dL to 5.5 mg/dL before taking one dose of Auryxia (i.e. baseline). At one and six months of treatment with Auryxia, 48 percent and 65 percent of patients, respectively, achieved serum phosphorus levels within the KDOQI guideline target range.Mean serum phosphorus levels:  At baseline, patients had a mean serum phosphorus level of 6.55 mg/dL, which was lowered to 5.41 mg/dL after six months of treatment with Auryxia. The reduction in serum phosphorus levels were comparable in patients taking Auryxia who switched from sevelamer and/or calcium and in patients new to binders.Daily tablets:  At baseline, patients were taking a mean of 11.7 tablets per day on their prior phosphate binder(s). Patients who stopped their prior phosphate binder(s) and switched to Auryxia had a mean tablet burden of 7.3 tablets per day at month six of treatment with Auryxia.Iron biomarker levels (TSAT and Ferritin): At baseline, mean hemoglobin, ferritin, and transferrin saturation were 10.6 g/dL, 734 ng/mL, and 27.1 percent, respectively. These levels increased by month three and were maintained through month six. After six months of treatment with Auryxia, these levels were 11.1 g/dL, 947 ng/mL, and 37 percent, respectively.Discontinuations: Five patients discontinued treatment after three months of treatment: three received kidney transplants, one discontinued dialysis and one was lost to follow-up.
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Nov 17, 2016
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Related Keywords Top-line Results, Phase Iii Study, Ferric Citrate, Auryxia, Iron Deficiency Anemia, Non-dialysis-dependent, Chronic Kidney Disease