This article is more than 5 years old. Information may no longer be current.

Ferric citrate meets goals in phase 3 study for iron deficiency anemia

Add topic to email alerts

Receive an email when new articles are posted on

Please provide your email address to receive an email when new articles are posted on .

Subscribe

Added to email alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

You've successfully added to your alerts. You will receive an email when new content is published.

Click Here to Manage Email Alerts

Back to Healio

We were unable to process your request. Please try again later. If you continue to have this issue please contact customerservice@slackinc.com.

Back to Healio

Keryx Biopharmaceuticals Inc. said ferric citrate met the goals of a Phase 3 study to treat iron deficiency anemia in adults with stage 3-5 non-dialysis dependent chronic kidney disease.

The study compared treatment with ferric citrate to placebo in 234 patients who previously had not adequately responded to or tolerated current oral iron therapies. The study achieved the primary endpoint with 52% (61/117) of patients who received ferric citrate achieving a 1g/dL or greater rise in hemoglobin at any time point during the 16-week randomized efficacy period, compared to 19% (22/115) in the placebo group (p<0.001).

The drug was approved under the brand name Auryxia to control serum phosphorus levels in patients with CKD on dialysis in September 2014 and launched in December 2014. The company said it would apply with U.S Food and Drug Administration an expanded approval.