Rockwell Medical announced that it has initiated enrollment in its second  Phase III clinical study called CRUISE-2, designed to treat iron deficiency anemia in hemodialysis dependent-chronic kidney disease patients receiving erythropoietin.

Rockwell is conducting two Phase III clinical trials for the iron-therapy drug 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.