Abstract
BACKGROUND: A sub-analysis of a Phase III study was conducted to identify factors that might predict increased ferritin levels during long-term sucroferric oxyhydroxide (SO) treatment in hemodialysis patients. METHODS: The open-label, multicenter, Phase III study assessed the efficacy and safety of SO 750-3000 mg/day for 52 weeks in Japanese patients with chronic renal failure and hyperphosphatemia. A total of 125 of 161 patients from the Phase III trial, and who had data for ferritin levels after 28 weeks of SO treatment, were evaluated. RESULTS: Baseline ferritin was the strongest contributor (P < 0.0001) to ferritin increases during SO treatment. By Week 28, there were significant differences (P < 0.05/3) in ferritin increases between patients with higher [quartile 4 (Q4)] versus lower (Q1, Q2 and Q3) baseline ferritin. An erythropoiesis-stimulating agent dosage reduction was observed in patients with the lowest baseline ferritin level (Q1), and only slight reductions were noted in the other patient subsets. SO dosages administered to patients in baseline ferritin quartiles Q2, Q3 and Q4 were comparable throughout the study with slight fluctuations. SO dosages in Q1 were considerably lower than those in the other quartiles. CONCLUSIONS: In summary, of the baseline variables found to predict increased ferritin, and changes in iron-related parameters, during SO treatment in Japanese chronic kidney disease patients undergoing hemodialysis, baseline ferritin was the most relevant variable.