Today, there is a product that can deliver iron consistently at every dialysis treatment in place of IV iron… it’s called Triferic.
Triferic is the only FDA approved drug indicated for the replacement of iron to maintain hemoglobin in adult patients with hemodialysis-dependent chronic kidney disease (HDD-CKD).
Dialysis patients lose approximately 5-7mg of iron at every dialysis treatment. This iron loss is a result of blood lost at every treatment due to needle sticks, blood trapped in blood lines and the dialyzer, and lab draws. This constant 5-7mg loss of iron is a primary driver of anemia in HD patients. There has been nothing to address this iron loss causing anemia until now, with Triferic.
Triferic delivers (replaces) 5-7 mg of iron at every dialysis treatment. Triferic is conveniently delivered via dialysate, enabling nurses to save considerable time from having to administer IV iron. But what makes Triferic special is that when it enters the blood (by crossing the dialyzer membrane) it immediately binds iron to transferrin and is transported to the bone marrow, helping generate red blood cells; there is no iron trapped in the liver, it does not induce iron overload, it does not increase inflammation or ferritin levels. Triferic is similar to the slower natural manner in which we receive iron from food to maintain hemoglobin.
Until Triferic, IV iron has been used to try and replace the ongoing iron loss in hemodialysis patients. But IV iron is a “repletion” therapy, and the majority of it (95%-98%) gets “trapped” in the liver instead of getting to the bone marrow to help make red blood cells and maintain hemoglobin. Iron trapped in the liver increases ferritin (marker of stored iron and inflammation) to high levels, which can cause iron overload and toxicity linked to cardiovascular disease. Today, in the U.S. the average ferritin in hemodialysis patients is 800 ug/L – 4-times higher than when IV iron use started in the 1990’s. IV iron is also associated with infections and life-threatening anaphylactic reactions.
(1) Fishbane S, Mathew AT, Wanchoo R. Clin J Am Soc Nephrol. 2014 Nov 7;9(11):1837-9. doi: 10.2215/CJN.09510914. Epub 2014 Oct 15. No abstract available.
Iron delivery during each dialysis treatment insures adequate iron availability for red blood cell formation, enabling ESA to be more effective in achieving hemoglobin in the target range.
- Iron delivered real-time at every dialysis treatment
- Replaces just the 5-7 milligrams of iron that is needed
- Maintains hemoglobin concentration
- Does not increase iron stores and inflammation (ferritin)
The safety profile of Triferic has been successfully demonstrated in long-term studies. Triferic has the largest safety database submitted for registration of any parenteral iron product. 1440 patients received Triferic every HD treatment for up to 18 months equaling 870 patient years of exposure. No anaphylaxis reported, no increase in intradialytic hypotension, no increase in infections, no iron toxicity or overload and no increase in oxidative stress or inflammation. Importantly, Triferic did show a decrease in blood transfusions of greater than 50% compared to placebo.
Triferic replaces iron real-time and maintains hemoglobin concentration without increasing iron stores.
PRIME ESA Sparing Study; Kidney International
CRUISE Phase 3 Studies; Nephrology Dialysis Transplantation
Iatrogenic Iron Overload in Dialysis Patients at the Beginning of the 21st Century; Adis Medical Journal
Pharmacokinetics of Ferric Pyrophosphate Citrate, a Novel Iron Salt, Administered Intravenously to Healthy Volunteers; The Journal of Clinical Pharmacology