Fixed-dose ferric citrate reduces anemia in advanced kidney disease

Takeaway

• Ferric citrate coordination complex (FCCC) improved anaemia and biochemical parameters in a pilot study of patients with advanced chronic kidney disease transitioning to dialysis.

Why this matters

• Fixed-dose FCCC may attenuate haemoglobin (Hb) decline and reduce the need for rescue therapy prior to dialysis.

Study design

• Randomised study of 199 patients with estimated glomerular filtration rate ≤20 mL/minute/1.73 m², receiving 2 FCCC tablets/meal (210 mg ferric iron/tablet [max, 6/day] n=133) or usual care (n=66) for 9 months or until 3 months postdialysis.
• Funding: Keryx Biopharmaceuticals, Inc.   

Key results

• Mean baseline Hb, 11-11.3 g/dL; mean transferrin saturation (TSAT), 23%-25%.
• FCCC significantly increased Hb, TSAT, and serum ferritin vs usual care (all P<.001).
• FCCC-treated patients less commonly required epoetin alpha (6% vs 15%; P=.03) and received a lower mean dose (4450±4870 vs 7521±13,312 U/week).
  • Intravenous iron was also less frequently used (3% vs 17%; P=.001) and at a lower mean dose (113±73 vs 113±171 mg/week).
• Levels of intact fibroblast growth factor 23 (FGF23) remained steady with FCCC but increased with usual care (P<.001).
• FCCC yielded a higher rate of target-range serum phosphate at month 9 (70% vs 45%; P=.03).
• Adverse events included discolored faeces (28%), constipation (12%), diarrhoea (9%); none were serious.

Limitations

• Open-label design.