Long-Term Effect of Ferric Citrate Hydrate on Mineral Metabolism and Anemia in Maintenance Hemodialysis Patients

Background: Ferric citrate hydrate is a phosphate (P)-binder drug that is indicated for patients with chronic kidney disease (CKD) undergoing maintenance hemodialysis (MHD). Objectives: The objectives of this study were to evaluate the changes in the serum mineral metabolism biomarker levels and treatment status of anemia in MHD patients receiving ferric citrate hydrate. Methods: A total of 132 adult dialysis patients were enrolled in this study. Bone turnover marker levels, anemia status and iron biomarker levels over a period of 18 months after the start of the ferric citrate hydrate treatment were extracted from the medical records of the patients. Results: At enrollment, 14 (10.6%) patients were P-binder-naïve, and 118 (89.4%) patients were receiving other P-binders. The serum P level before the start of ferric citrate hydrate treatment was ≤5.5 mg/dL in 18.8% of the patients. After 18 months of ferric citrate hydrate treatment, the proportion of patients with serum P levels ≤ 5.5 mg/dL increased to 47.7%. The mean ± standard error of the mean (SEM) of the serum P level was 7.05 ± 0.14 mg/dL at the baseline, and decreased to 5.83 ± 0.17 mg/dL after 18 months of treatment with ferric citrate hydrate. The mean ± SEM of the serum hemoglobin (Hb), ferritin, and transferrin saturation (TSAT) levels were 11.96 ± 0.76 g/dL, 71.13 ± 6.09 ng/mL, and 25.19% ± 1.21%, respectively, at the baseline, and 11.45 ± 0.13 g/dL, 124.94 ± 8.62 ng/mL, and 26.18% ± 0.99%, respectively, after 18 months of ferric citrate hydrate treatment. Conclusions: These results suggest that the serum P and anemia biomarker levels observed in this study were similar to those reported in clinical trials.