Oral ferric citrate may affectively raise hemoglobin levels in patients with anemia.
A new study found that anemia may be effectively treated by an oral iron drug in patients with kidney disease.
According to a study published by the Journal of the American Society of Nephrology, 52.1% of patients treated with oral ferric citrate had increased levels of hemoglobin, compared with only 19.1% of patients treated with placebo.
The investigators observed this beneficial effect after only 1 to 2 weeks of treatment, and noted that the effects were long-lasting. These findings may present patients with an alternative treatment option to intravenous iron.
Approximately 30 million Americans have chronic kidney disease, and more than half also have iron deficiencies. However, a majority of patients do not receive treatment for low iron, and progress to develop anemia.
Anemia is characterized by fatigue, weakness, pale skin, dizziness, and other common symptoms that may not immediately indicate a deficiency. Currently, the only FDA-approved treatment is an intravenous formulation of iron, Injectafer (ferric carboxymaltose injection), which can cause anaphylaxis in some patients.
In an attempt to mitigate serious adverse events and effectively treat anemia in patients with chronic kidney disease, the researchers conducted a phase 3 clinical trial to determine whether oral ferric citrate can safely and effectively treat these patients.
Included in the study were 117 patients treated with oral ferric citrate and 115 treated with placebo. The primary endpoint was the number of patients with achieved a ≥1.0-g/dl increase in hemoglobin during the 16-week period, according to the study.
Treatment efficacy of oral ferric citrate was reported as early as week 1, and more than half of patients receiving the drug achieved the primary endpoint. Serious adverse events experienced by both groups of patients were similar, with 12% in the ferric citrate group and 11.2% in the placebo group experiencing complications.
Gastrointestinal conditions, such as diarrhea and constipation were common, but they were typically mild to moderate in severity, according to the study.
"Secondary endpoints related to correction of anemia and lowering of serum phosphate were also reached in ferric citrate-treated patients. In addition, exploratory endpoints showed improvements in other parameters of mineral metabolism in ferric citrate-treated patients," said researcher Glenn Chertow, MD, MPH.
Ferric citrate also works as an intestinal phosphate binder, and has received approval for the treatment of hyperphosphatemia in patients undergoing dialysis treatment, according to the study. If the findings are confirmed in additional trials, the drug development process for this indication will drastically speed up.
Although oral ferric citrate worked well to improve hemoglobin levels, additional research is needed to determine the effect the drug has on prolonging life, or improving the quality of life, the study concluded.