Rockwell Medical Starts Pivotal Phase III Clinical Study for Treatment of Iron Deficiency in Dialysis Patients

Rockwell Medical RMTI announced today that it has commenced enrollment in its pivotal Phase III CRUISE-1 clinical study, designed to treat iron deficiency anemia in hemodialysis dependent-chronic kidney disease patients receiving erythropoietin. Rockwell is conducting two pivotal Phase III clinical trials for SFP called CRUISE-1 and CRUISE-2. Each study is a prospective, randomized, double-blinded, 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.