The Phosphate Binder Ferric Citrate and Mineral Metabolism and Inflammatory Markers in Maintenance Dialysis Patients: Results From Prespecified Analyses of a Randomized Clinical Trial

摘要: Background Phosphate binders are the cornerstone of hyperphosphatemia management in dialysis patients. Ferric citrate is an iron-based oral phosphate binder that effectively lowers serum phosphorus levels. Study Design 52-week, open-label, phase 3, randomized, controlled trial for safety-profile assessment. Setting & Participants Maintenance patients with levels ≥6.0mg/dL after washout prior binders. Intervention 2:1 randomization to ferric or active control (sevelamer carbonate and/or calcium acetate). Outcomes Changes mineral bone disease, protein-energy wasting/inflammation, and occurrence adverse events 1 year. Measurements Serum calcium, intact parathyroid hormone, phosphorus, aluminum, white blood cell count, percentage lymphocytes, urea nitrogen, bicarbonate. Results There were 292 participants randomly assigned citrate, 149, control. Groups well matched. For mean changes from baseline, levels decreased similarly groups (−2.04±1.99 [SD] vs −2.18±2.25mg/dL, respectively; P =0.9); increased (0.22±0.90 vs 0.31±0.95mg/dL; =0.2). Hypercalcemia occurred 4 receiving acetate. Parathyroid hormone (−167.1±399.8 vs −152.7±392.1pg/mL; =0.8). albumin, bicarbonate, count aluminum values similar between Total low-density lipoprotein cholesterol lower sevelamer than those Fewer had serious compared Limitations Open-label study, few peritoneal Conclusions was associated control, effects on markers metabolism no evidence wasting/inflammation toxicity, fewer events. effective a safety profile comparable