Abstract
We explored the long-term safety and efficacy of ferric citrate in hemodialysis patients in Taiwan, and further evaluated the iron repletion effect and change of iron parameters by different baseline groups. This was a 12-month, Phase IV, multicenter, open-label study. The initial dose of ferric citrate was administered by patients' clinical condition and further adjusted to maintain serum phosphorus at 3.5-5.5 mg/dL. The primary endpoint was to assess the safety profiles of ferric citrate. The secondary endpoints were to evaluate the efficacy by the time-course changes and the number of subjects who achieved the target range of serum phosphorus. A total of 202 patients were enrolled. No apparent or unexpected safety concerns were observed. The most common treatment-emergent adverse events were gastrointestinal-related with discolored feces (41.6%). Serum phosphorus was well controlled, with a mean dose of 3.35±1.49 g/day, ranging from 1.5 to 6.0 g/day. Iron parameters were significantly improved. The change from baseline of ferritin and TSAT were 227.17 ng/mL and 7.53%, respectively (p-trend<0.001), and the increase started to slow down after 3-6 months of treatment. In addition, the increase trend was found only in patients with lower baseline level of ferritin (≤500 ng/mL) and TSAT (<30%). Ferric citrate is an effective phosphate binder with favorable safety profile in ESRD patients. The iron-repletion by ferric citrate is effective, and the increase is limited in patients with a higher baseline. In addition to controlling hyperphosphatemia, ferric citrate also shows additional benefits in the treatment of renal anemia. ClinicalTrials.gov ID: NCT03256838; 12/04/2017.
Highlights
Hyperphosphatemia and anemia are the two most frequent complications encountered in end-stage renal disease (ESRD) patients
The most common treatment-emergent adverse events were gastrointestinalrelated with discolored feces (41.6%)
The iron-repletion by ferric citrate is effective, and the increase is limited in patients with a higher baseline
Summary
Hyperphosphatemia and anemia are the two most frequent complications encountered in end-stage renal disease (ESRD) patients. Hemodialysis and peritoneal dialysis are standard modalities for ESRD patients. Dialysis patients still suffer from hyperphosphatemia due to the average intake of phosphorus in the gastrointestinal tract as high as 900 mg/day [4, 5]. Traditional phosphate binders are used to reduce phosphorus absorption in the gastrointestinal tract, which may lead to adverse results such as hypercalcemia, systemic toxicity, gastroduodenal lesions, or lower adherence rates due to heavy pill burden and inconvenient formulations [6]. With its additional benefits of iron supplementing for renal anemia, iron-based phosphate binder has become a popular choice for CKD patients [7, 8]. We explored the long-term safety and efficacy of ferric citrate in hemodialysis patients in Taiwan, and further evaluated the iron repletion effect and change of iron parameters by different baseline groups
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