American Regent announced on April 24 that the first patients had enrolled in a phase 3 trial evaluating an investigational heart failure medication.
During the study, known as HEART-FID, the researchers plan on randomizing more than 3,000 U.S. adults with heart failure, iron deficiency and a reduced ejection fraction to receive intravenous ferric carboxymaltose or placebo.
Patients will initially receive two, 15 mg/kg doses of ferric carboxymaltose to a maximum individual dose of 750 mg and a maximum combined dose of 1,500 mg seven days apart. They will receive doses every six months depending on iron indices.
The primary endpoint is the combination of the 12-month rate of death, hospitalization for worsening heart failure and the six-month change in six-minute walk test.
Adrian F. Hernandez, MD, of the Duke Clinical Research Institute, is the study’s chairman. The trial is currently enrolling patients at four sites in Florida, three sites in Texas and one site apiece in Alabama, Arizona, California Massachusetts, New Jersey and South Carolina.
The FDA has not approved ferric carboxymaltose, which is an intravenous form of iron intended to treat iron deficiency anemia. As many as 50 percent of the 6.5 million U.S. adults with heart failure have iron deficiency, according to American Regent. American Regent is a division of Luitpold Pharmaceuticals, which is subsidiary of Daiichi Sankyo.