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ARTICLE | Clinical News

Daiichi starts Phase III HEART-FID trial of iron therapy for heart failure

May 11, 2017 7:36 PM UTC

American Regent Inc. began the Phase III HEART-FID trial of ferric carboxymaltose (Z-213) to treat heart failure with iron deficiency and reduced ejection fraction in about 3,014 patients. The double-blind, U.S. trial will evaluate incidence of death, incidence of hospitalization for heart failure and change in the 6-minute walk test (6MWT) distance. Patients will receive up to 750 mg IV ferric carboxymaltose or placebo on days 0 and 7 every 6 months.

The product is approved as Injectafer in the U.S. to treat iron deficiency anemia in adults who have not responded to or are intolerant to oral iron and in adults with non-dialysis dependent chronic kidney disease (CKD). It is approved as Ferinject elsewhere to treat iron deficiency anemia where oral iron is ineffective or cannot be used...