Rockwell Medical has completed patient dosing in its CRUISE-1 Phase 3 efficacy study for SFP, an experimental iron-delivery drug for the treatment of iron deficiency in chronic kidney disease patients receiving hemodialysis. CRUISE-1 top-line data is expected in July 2013, Rockwell said.
"Completing the CRUISE-1 efficacy study is a major milestone achievement for Rockwell, and we are excited to be so close to top-line results," said Robert L. Chioini, Founder, Chairman and CEO of Rockwell Medical.
The CRUISE Studies
Rockwell is conducting two pivotal Phase 3 efficacy studies 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 comprises approximately 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.