ORLANDO, Fla.—Triferic (ferric pyrophosphate citrate) administered during hemodialysis (HD) or intravenously rapidly donates iron to transferrin and is cleared quickly from the circulation, according to new findings presented at the National Kidney Foundation’s 2017 Spring Clinical Meetings.
The drug, which was approved by the FDA in January 2015 to maintain hemoglobin levels in dialysis patients, delivers a mean of 6.6 mg of iron with each hemodialysis treatment, reported Raymond D. Pratt, MD, and Ajay Gupta, MD, of Rockwell Medical Inc., Wixom, Michigan, the maker of Triferic.
The researchers conducted a pharmacokinetics study that included 13 chronic HD patients with a mean age of 49.2 years. In randomized order following a baseline dialysis session, investigators exposed patients to 3 different Triferic dosing protocols: 2 µM of Triferic (110 µg Fe/L) via dialysate over 4 hours; a single 6.6 mg dose of Triferic administered IV over 3 hours during HD via the unused heparin infusion line (pre-dialyzer); and a single 6.6 mg dose of Triferic administered IV over 3 hours during HD via an infusion port (post-dialyzer). At different HD sessions, patients crossed over from one protocol to another.
Results showed that HD patients do not exhibit diurnal variations in serum iron concentrations unlike healthy volunteers. Triferic administered via dialysate delivers about 6.6 mg of iron with each treatment with a half-life of approximately 2.9 hours. The study also demonstrated that Triferic can be administered pre- or post-dialyzer with the same efficiency.
Dr Pratt noted that this is an important study in that it confirms that Triferic can be delivered directly into the blood via the arterial or venous blood line during the HD treatment. “This enables Triferic iron to be delivered to patients who receive their treatment with dialysis machines using bicarbonate cartridges, the predominate form of bicarbonate delivery in Europe and other non-US countries,” he said. It also highlights Triferic’s unique mechanism of action in that it donates iron to transferrin for transport to the bone marrow for hemoglobin incorporation with no loss of Triferic to the dialysate. Finally, the study confirms that the amount of Triferic iron delivered via the dialysate with each HD treatment is approximately 6.5 mg, which matches the typical average iron loss that HD patients experience with each treatment, thus maintaining hemoglobin concentrations without increasing the body burden of iron.