"We are enthused to begin enrollment of our phase 3 pivotal study,” said Robert L. Chioini, chairman and CEO of Rockwell. “This trial commencement is a significant milestone for the company. Enrolling patients in CRUISE-1 in the first quarter of 2011 keeps our clinical development timeline for SFP on target."
Soluble Ferric Pyrophosphate (SFP) is delivered through dialysate and is designed to treat iron deficiency-anemia in ESRD patients. SFP is a water-soluble iron that travels to the bloodstream and binds directly to apo-transferrin and then travels to bone marrow to assist in forming a healthy red blood cell, similar to normal physiologic dietary iron intake, according to Rockwell.
SFP is a continuous iron replacement treatment, delivering small doses of iron during every dialysis session, to replenish the 5-7mg of iron lost during the dialysis procedure, thereby maintaining hemoglobin in the target range as per Kidney Disease Quality Outcomes Initiative (KDQOI) recommendations.
Rockwell is conducting two pivotal phase 3 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 include 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.
