Results from an open-label investigator-sponsored study assessing Keryx Biopharmaceuticals’ (NASDAQ:KERX) Auryxia (ferric citrate) in patients with advanced chronic kidney disease (CKD) showed its potential for delaying the need for dialysis. The data were presented at ERA/EDTA in Copenhagen.
The study evaluated ferric citrate compared to standard-of-care (SOC) treatment in late-stage non-dialysis dependent CKD patients who were not expected to start dialysis within eight weeks of study initiation. Participants were randomized 2:1 to receive either a fixed dose of Auryxia (two tablets per meal) or SOC.
In the ferric citrate group, 76 of 133 patients completed the nine months of the study. 30 initiated dialysis, 16 terminated early, eight received a transplant and three died.
In the SOC group, 29 of 66 patients completed the study. 31 initiated dialysis, four terminated early and two died (dialysis results should be based on those who completed the study but 31 > 29).
Geoffrey Block, M.D, Director of Clinical Research at Denver Nephrology says, “The data from this study suggest that administering ferric citrate to late-stage pre-dialysis patients not only improves biochemical parameters associated with chronic kidney disease, but also has the potential to delay the need for dialysis. With the impact of ferric citrate across multiple aspects of CKD, it is worth further investigation to determine which of these many factors is contributing to the reduced risk of renal replacement therapy observed in this study.”
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