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April 24, 2017

American Regent begins enrolment in Phase III trial of Injectafer to treat heart failure

Japanese pharmaceutical firm Daiichi Sankyo's division, American Regent, has begun patient enrolment in the Phase III HEART-FID clinical trial of Injectafer (ferric carboxymaltose) for the treatment of heart failure with iron deficiency.

Japanese pharmaceutical firm Daiichi Sankyo's division, American Regent, has begun patient enrolment in the Phase III HEART-FID clinical trial of Injectafer (ferric carboxymaltose) for the treatment of heart failure with iron deficiency.

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Injectafer is an intravenous (IV) form of iron being developed for the treatment of iron deficiency anaemia (IDA) in adults with an intolerance to oral iron or unsatisfactory response to oral iron or non-dialysis dependent chronic kidney disease.

The double-blind, multi-centre, prospective, randomised, placebo-controlled Phase III trial is expected to enrol more than 3,000 adult patients across North America.

The trial will evaluate the efficacy and safety of iron therapy using IV ferric carboxymaltose (FCM) as compared to placebo in heart failure patients with iron deficiency and a decreased ejection fraction.

"Heart failure in relation to iron deficiency is an important area of research for American Regent."

American Regent clinical research and development head Sumita Chowdhury said: "We are pleased to enrol our first patient in the HEART-FID trial, one of the largest studies looking at this specific condition, and we look forward to further recruitment.

"Heart failure in relation to iron deficiency is an important area of research for American Regent."

The trial's primary objectives are measuring one-year death rates, hospitalisation for worsening heart failure and the six-month change in the six-minute walk test (6MWT).

Eligible subjects will be divided by region and randomised in a 1:1 ratio to FCM or placebo for treatment, following an initial screening period of about 28 days.

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