Ash Medical Systems patented an original concept of delivering iron to dialysis patients by adding small amounts to dialysate. The concept was later validated by publication of results of Dr. Gupta of Henry Ford Hospital, showing this addition was safe and effective. Recombinant EPO is effective in increasing hematocrit of patients with adequate iron stores, but the increased rate of production of new red cells quickly depletes body iron stores. When iron stores become depleted, EPO becomes completely ineffective. Patients are directed to take oral iron tablets when EPO is started, but oral iron is absorbed very slowly, and patients often stop taking these medications because of side effects such as constipation.
Infed administration is effective, but is also expensive and time-consuming.
Since free iron concentrations within plasma are nearly zero, dialysis losses of iron are insignificant, even though there is no iron included in dialysate. This product has been available in Europe for several years. Within the body, principally the liver, ferric gluconate is reduced and then separates into single molecules of ferrous gluconate. Then the gluconate portion is metabolized and the iron becomes free to attach to transferring in the blood. The iron is transferred from transferring to hemoglobin being formed in red cell precursors within the bone marrow.