Stanford, California—Iron deficiency is a problem for more than half of the 30 million U.S. adults with chronic kidney disease (CKD). Treatment options generally have been limited to IV iron products approved by the FDA.

A new study published in the Journal of the American Society of Nephrology sought to determine if an oral iron formulation also might be a safe and effective treatment for anemia in patients with CKD.

Stanford University School of Medicine–led researchers conducted a phase 3 randomized double-blind clinical trial where 117 patients received oral ferric citrate and 115 received placebo. In addition to improving iron levels, ferric citrate also functions as an intestinal phosphate binder and has been approved for the treatment of hyperphosphatemia in patients on dialysis.

During the trial, 52.1% of patients receiving ferric citrate achieved the primary end point of increasing hemoglobin levels, compared with 19.1% of patients receiving placebo during a 16-week randomized period. Patients who completed the 16-week period could also participate in an 8-week open-label extension period.

While a treatment effect was seen within weeks after the start of treatment, rates of serious adverse events were similar between the ferric citrate (12.0%) and placebo groups (11.2%), according to the results. The most common adverse events were gastrointestinal disorders such as diarrhea and constipation, and those tended to be mild or moderate.

“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,” explained corresponding author Glenn Chertow, MD, MPH.
 
“Overall, in patients with NDD-CKD, we found oral ferric citrate to be a safe and efficacious treatment for iron deficiency anemia,” study authors conclude.

Chertow added that, although oral ferric citrate boosted hemoglobin levels in the study, additional research is needed to see if the drug prolongs life or improves patients' quality of life.

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