Abstract
BackgroundFerric citrate hydrate (FC) is an oral iron-based phosphate binder that is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD). This post-marketing surveillance study was performed to investigate the long-term safety and effectiveness of FC.MethodsThis prospective, multicenter, observational post-marketing surveillance study was performed in a real-world setting in Japan. The study involved CKD patients with hyperphosphatemia receiving FC who were undergoing either hemodialysis or peritoneal dialysis or were non-dialysis-dependent. Adverse drug reactions, iron- and erythrocyte-related parameters (i.e., levels of serum ferritin, transferrin saturation, and hemoglobin), and serum levels of phosphorus, corrected calcium, and intact parathyroid hormone were monitored for up to 104 weeks.ResultsSafety was evaluated in 2723 patients. Of these patients, 20.5% discontinued FC because of adverse events, and 3.9% discontinued FC because of unsatisfactory effectiveness. Iron-related parameters gradually increased after the initiation of FC treatment but stabilized after week 36. Effectiveness was analyzed in 2367 patients. Serum phosphorus immediately decreased, and the effect persisted for 104 weeks.ConclusionIn this 104 week surveillance study, no new safety concerns were noted. The safety profile was not obviously different from those in pre-approval clinical trials and the 52 week interim report of this surveillance study. The serum ferritin level of most patients was below the upper limit of the target range, and iron overload risk was not evident. Long-term FC treatment effectively controlled serum phosphorus.
Highlights
In patients with chronic kidney disease (CKD), declining kidney function results in CKD-mineral and bone disorder (CKD-MBD), which includes hyperphosphatemia, hypercalcemia, hyperparathyroidism, and impaired bone metabolism
CKD patients who were undergoing hemodialysis and/or peritoneal dialysis or were non-dialysis-dependent were eligible for this surveillance study
The mean age ± standard deviation (SD) was 65.6 ± 13.0 years and the proportion of men was 60.34% in the overall population, and there was no notable difference among patients in the HD, peritoneal dialysis (PD), ND, and other treatment (OT) groups
Summary
In patients with chronic kidney disease (CKD), declining kidney function results in CKD-mineral and bone disorder (CKD-MBD), which includes hyperphosphatemia, hypercalcemia, hyperparathyroidism, and impaired bone metabolism. FC is an oral iron-based phosphate binder that effectively controls the serum P concentration in patients undergoing hemodialysis [8] or peritoneal dialysis [9] and in non-dialysis-dependent CKD patients [10]. In Japan, FC has been approved to treat hyperphosphatemia in patients undergoing dialysis and in non-dialysis-dependent patients since 2014. Ferric citrate has been shown to increase the hemoglobin level in patients with iron-deficiency anemia without CKD [11], with CKD undergoing hemodialysis [12], and with non-dialysis-dependent CKD [13]. Ferric citrate hydrate (FC) is an oral iron-based phosphate binder that is used to treat hyperphosphatemia in patients with chronic kidney disease (CKD). This post-marketing surveillance study was performed to investigate the longterm safety and effectiveness of FC.
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