Dialysate Drug Maintains Hemoglobin Levels

Triferic, a drug approved for iron delivery through dialysate, has met its primary endpoints in two phase 3 CRUISE studies (CRUISE 1 and 2), according to published data in Nephrology Dialysis Transplantation (1). Manufactured by Rockwell Medical (Wixom, MI), Triferic is the only drug so far in the US to win approval from the US Food and Drug Administration (FDA) for delivery via dialysate to replace iron and maintain hemoglobin in patients undergoing hemodialysis. Approval came in January 2015, and the two postapproval safety and efficacy studies were recommended but not required.

The primary objective of the CRUISE studies was to determine whether regular administration of Triferic via dialysate could maintain hemoglobin concentrations by optimizing iron delivery and maintaining iron balance.

A total of 599 patients participated in both studies, with 290 randomized to receive Triferic and 295 to receive placebo. The patients completed the phase 3 study when they met prespecified anemia criteria or went 48 weeks without reaching the criteria levels.

The primary endpoint was the mean change in hemoglobin from baseline to the end of treatment.

In both studies, the study drug met the primary endpoint with a treatment difference of 0.4 g/dL in hemoglobin concentration in the Triferic group (p = 0.011 for individual studies, 95% confidence interval 0.1–0.6 g/dL) compared with the placebo group; hemoglobin levels held steady in the Triferic group but declined in the placebo group, Rockwell Medical noted. The safety profile of Triferic was similar to that in placebo-treated patients; both groups experienced similar percentages of adverse events, Rockwell Medical said.

Steven Fishbane, MD, lead author of the study, nephrologist and chief of the division of kidney diseases and hypertension, North Shore University Hospital and Long Island Jewish Medical Center, noted, “Triferic is administered at each dialysis session and its iron is immediately donated to transferrin, very similar to the slower, natural way iron is used in the body to maintain hemoglobin.” He said that patients undergoing dialysis have been treated almost exclusively with intravenous iron for iron replacement, which “injects a large amount of iron directly into the bloodstream and gets sequestered in the liver, resulting in higher and higher ferritins.”

Reference

1. 

Fishbane SN, et al. Ferric pyrophosphate (Triferic) administration via the dialysate maintains hemoglobin and iron balance in chronic hemodialysis patients. Nephrol Dial Transplant 2015 Jul 13 [Epub ahead of print].