Abstract
Ferric citrate hydrate (FC) is an iron-based phosphate binder approved for hyperphosphataemia in patients with chronic kidney disease. We conducted a randomised controlled trial to evaluate the effects of FC on anaemia management in haemodialysis patients with hyperphosphataemia. We 1:1 randomised 93 patients who were undergoing haemodialysis and being treated with non-iron-based phosphate binders and erythropoiesis-stimulating agents (ESA) to receive 24 weeks of FC or to continue their non-iron-based phosphate binders (control) in a multicentre, open-label, parallel-design. Phosphate level was controlled within target range (3.5–6.0 mg/dL). The primary endpoint was change in ESA dose from baseline to end of treatment. Secondary endpoints were changes in red blood cell, iron and mineral, and bone-related parameters. Compared with control, FC reduced ESA dose [mean change (SD), −1211.8 (3609.5) versus +1195 (6662.8) IU/week; P = 0.03] without significant differences in haemoglobin. FC decreased red blood cell distribution width (RDW) compared with control. While there were no changes in serum phosphate, FC reduced C-terminal fibroblast growth factor (FGF) 23 compared with control. The incidence of adverse events did not differ significantly between groups. Despite unchanged phosphate and haemoglobin levels, FC reduced ESA dose, RDW, and C-terminal FGF23 compared with control.
Highlights
In patients undergoing haemodialysis, hyperphosphataemia and anaemia are complex management challenges[1,2]
The proportion of discontinuations because of adverse events was higher in the Ferric citrate hydrate (FC) (n = 8) versus the control group (n = 1), Treatment-related adverse events leading to withdrawal of FC included diarrhoea and pruritus (Day 7), constipation (Day 7), nausea (Day 17) and rectal tenesmus (Day 49)
The prospective, multicentre ASTRIO study compared the effects of FC versus non-iron-based phosphate binders on anaemia management among Japanese patients who were undergoing maintenance haemodialysis and were receiving phosphate binders for treatment of hyperphosphataemia and erythropoiesis-stimulating agents (ESA) for treatment of anaemia
Summary
Hyperphosphataemia and anaemia are complex management challenges[1,2]. ® Clinical studies of ferric citrate (Auryxia , Keryx Biopharmaceuticals, Inc., Boston, USA) in patients with hyperphosphataemia undergoing maintenance haemodialysis showed reductions in serum phosphate, and reductions in doses of ESA and intravenous (IV) iron, likely because of increased iron absorption during ferric citrate administration. These studies were conducted in the United States and Israel, where ESA and IV iron www.nature.com/scientificreports/. We tested the hypothesis that treatment with FC would provide comparable control of hyperphosphataemia while simultaneously providing superior treatment of renal anaemia compared with non-iron-based phosphate binders in patients with hyperphosphataemia and anaemia who were undergoing haemodialysis and ESA therapy
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