Investigational drug effective in treating iron deficiency in kidney disease patients on dialysis

Chronic kidney disease (CKD) is the slow loss of kidney function over time. The main function of the kidneys is to remove wastes and excess water from the body. When chronic kidney failure reaches an advanced stage, dangerous levels of fluid, electrolytes and wastes can accumulate in the body, and a patient will need to undergo hemodialysis (dialysis) -- a machine that filters wastes, salts and fluid from the blood. A common problem for patients on dialysis is iron deficiency. The body needs a certain amount of iron for overall good health and healthy blood cells, but excess iron gradually builds up in tissues and organs, eventually damaging them. Standard, current care for dialysis patients with iron deficiency is to intravenously inject 100 mg of iron into the bloodstream. But this method can result in oxidative stress and harm to people on dialysis.

Steven Fishbane, MD, and Azzour Hazzan, MD from the North Shore-LIJ Health System's Division of Nephrology in New York, in collaboration with Ajay Singh, MD, associate professor at Harvard Medical School, conducted two Phase 3 trials, CRUISE-1 and CRUISE-2, which demonstrated, in 300 patients in each trial, that Triferic administered at each dialysis treatment for up to 48 weeks effectively delivers iron and maintains the body's hemoglobin concentration constant. Triferic is a novel iron compound that has a unique mode of action in that it is delivered to the patient via their dialysis treatment as opposed to intravenous delivery. Triferic gradually delivers iron to the bone marrow and maintains hemoglobin without the rapid flux of iron caused by intravenous injection.

"Up until now, iron deficiency in chronic kidney disease patients who undergo dialysis has been treated almost exclusively with intravenous iron, which injects a large amount of iron directly into the blood stream. This can potentially be toxic for patients," said Dr. Fishbane. "Our study is important and should be of interest to patients because it shows Triferic is effective in preventing iron deficiency without inducing iron overload in patients. It more closely mimics the slower natural way of absorbing iron and with additional studies, we might be able to show it is an improved and preferred treatment option."