WIXOM, Mich.—Rockwell Medical announced April 26 that it has initiated enrollment in its second pivotal Phase III clinical study called CRUISE-2, designed to treat iron deficiency anemia in hemodialysis dependent-chronic kidney disease patients receiving erythropoietin.
Robert L. Chioini, Chairman and CEO of Rockwell stated, "We are pleased to have both Phase III studies enrolling patients. Based on the data to date, we believe that SFP provides anemic dialysis patients with a safe, physiologic alternative for iron delivery. We look forward to positive results from the CRUISE studies."
Rockwell is conducting two pivotal Phase III clinical trials for SFP called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, placebo-controlled, multicenter study to demonstrate efficacy and safety of SFP-iron, delivered via dialysate, in adult CKD patients requiring hemodialysis. Each study will comprise 300 patients, randomized equally between SFP and placebo groups with a treatment period of up to 12 months. The primary efficacy end-point for both studies is the mean change in hemoglobin from baseline.
