WIXOM, Mich.—The clinical research divisions if the two largest dialysis companies have signed agreements to participate in Rockwell Medical’s phase III studies using Soluble Ferric Pyrophosphate (SFP) as a continuous iron replacement therapeutic.
"We are pleased to have these companies participate in our pivotal SFP Phase III studies,” said Robert L. Chioini, Chairman and CEO, stated. “Together, they provide ongoing dialysis treatment to approximately two-thirds of hemodialysis patients in the U.S. We expect their access to a large number of patients and their expertise in clinical research will enable us to achieve timely enrollment and complete a successful Phase III clinical program."
Rockwell said it will conduct two pivotal Phase III trials for SFP. 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 over a period of up to 12 months.
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.
