New Iron Formula Boosts Hb During Dialysis

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Endocrinology

New Iron Formula Boosts Hb During Dialysis
By Kristina Fiore, Staff Writer, MedPage Today
Published: July 11, 2013
An investigational iron replacement agent significantly raised hemoglobin levels compared with placebo among hemodialysis patients with chronic kidney disease, according to top-line results from a trial.

In the phase III CRUISE-1 trial, patients taking soluble ferric pyrophosphate (SFP) had a significantly greater increase in mean hemoglobin from baseline compared with those on placebo, (mean differences 3.6 g/L, P=0.011), drugmaker Rockwell Medical announced in a press release.

SFP is an iron compound delivered to dialysis patients via dialysate, replacing the 5 mg to 7 mg of iron lost during a dialysis treatment. Once in the blood stream, it binds to apo-transferrin and is taken into the bone marrow.

The single-blind, controlled, parallel-group trial enrolled patients on regular hemodialysis who were getting stable doses of erythropoiesis stimulating agents (ESAs) and were iron replete, for a total of 48 weeks.

Patients couldn't have their ESA doses adjusted from baseline, and they weren't allowed to have IV or oral iron.

The researchers found that SFP met the primary endpoint of significantly changing mean hemoglobin from baseline compared with placebo (mean difference 3.6 g/L, P=0.011).

With regard to secondary endpoints, patients in the drug group had levels of reticulocyte hemoglobin, a marker of iron delivery to the bone marrow, that were 2.1% higher at the end of treatment compared with those in the placebo group (P<0.001).

Also, levels of serum ferritin, a marker of tissue iron stores, dropped less in the SFP group by study end (-14.7% versus -28.2%, P<0.001).

At the same time, the drug did not lead to an increase in serum ferritin, the company noted.

"The positive reticulocyte hemoglobin and ferritin data demonstrate that iron from SFP is directed at erythropoiesis and is not increasing iron stores," chief medical officer Raymond Pratt said in a statement.

Adverse event rates were similar between groups, with no occurrences of anaphylaxis or hypersensitivity events. Nor were there any increases in hypotension or infection with the drug.

"The data show that in place of IV iron, SFP is a safe and effective iron replacement therapy that consistently maintains hemoglobin levels without increasing iron stores," CEO and founder Rob Chioini said in a statement. "We believe SFP is positioned to become the new standard of care in iron therapy."

The company noted that the CRUISE-2 trial is underway and is expected to be completed soon.

http://www.medpagetoday.com/Endocrinology/GeneralEndocrinology/40415