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Efficacy and safety of PT20, an iron-based phosphate binder, for the treatment of hyperphosphataemia: A randomized, double-blind, placebo-controlled, dose-ranging, phase IIb study in patients with haemodialysis-dependent chronic kidney disease

Nephrology Dialysis Transplantation Jul 15, 2020

Sampson M, Faria N, Powell JJ, et al. - Whether oral PT20 (ferric iron oxide adipate) treatment administered for 28 days would be an efficacious and safe strategy to treat hyperphosphataemia in patients with dialysis-dependent chronic kidney disease (CKD) was investigated in this double-blind, parallel-group, placebo-controlled, dose-ranging study. Patients were randomized, in an 8:8:8:13:13 ratio, to receive PT20 (400, 800, 1600 or 3200 mg) or placebo three times daily. A statistically significant as well as dose-dependent decline in serum phosphate level was noted as a consequence of PT20 treatment for 28 days. Gastrointestinal, primarily diarrhoea (13–18%) and discoloured faeces (3–23%) were reported as the most common PT20 treatment-related adverse events. Overall, in this first inquiry of PT20 for hyperphosphataemia in patients with dialysis-dependent CKD, findings revealed not only the generally good tolerability of PT20 but also its efficacy in significantly lowering serum phosphate levels in these patients.

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