Amgen publishes results of Aranesp phase III trial

Amgen has announced the results of a phase III trail of Aranesp Therapy (TREAT) in chronic kidney disease (CKD) patients with type-2 diabetes.

The study, which involved non-dialysis-treated patients with CKD, focused on the treatment of anemia with Aranesp (darbepoetin alfa) to a hemoglobin target of 13 g/dL.

It concluded that the drug had no statistically significant effect on either of two primary endpoints when compared with placebo treatment.

These endpoints were a composite of time to all-cause mortality or cardiovascular morbidity and a composite of time to all-cause mortality or chronic renal replacement therapy.

Roger Perlmutter, executive vice-president of research and development at Amgen, said: “We continue to believe that ESAs (erythropoiesis-stimulating agents) have a favorable benefit [to] risk profile when used according to the approved label.”

Last week, Amgen announced positive top-line results from a phase III trial into Vectibix (panitumumab) in combination with irinotecan-based chemotherapy FOLFIRI.