Clinical Data
The open-label, single-center study evaluated use of ferric citrate compared to standard of care treatment (SOC) in late-stage non-dialysis dependent CKD patients. Patients with eGFR < 20 ml/min who were not anticipated to start renal replacement therapy (dialysis) within 8 weeks of study initiation were randomized 2:1 to receive a fixed dose of ferric citrate (two tablets per meal) or SOC. The data presented today are based on the 199 evaluable patients (133 in the ferric citrate-treated arm, and 66 in the SOC arm) who were seen for at least one follow up visit. Of those randomized to the standard of care arm, 37 percent received phosphate binders during the pre-dialysis period. Patients enrolled in the study were seen monthly for 9 months, or, for those who started dialysis treatment, for three months post dialysis initiation. The data presented today are related to the non-dialysis period of the study (9 months for those who did not progress to dialysis or the time leading up to dialysis for patients who progressed).