Investigational Iron Drug Safe, Effective in Hemodialysis Patients
Soluble ferric pyrophosphate (SFP), an investigational parenteral iron formulation, maintains hemoglobin (Hb) levels better than placebo in hemodialysis (HD) patients, according to the results of a phase 3 study.
The CRUISE-1 efficacy study included 300 HD patients randomized to receive SFP (149 patients) or placebo (151 patients). At baseline, the two groups had similar Hb levels (109.6 and 10.9.0 g/L in the SFP and placebo arms, respectively). From baseline to the end of the randomized treatment period, the SFP arm had a mean 0.6 g/L increase in Hb level and the placebo arm had a 3.0 g/L decrease, according to data reported by the drug's developer, Rockwell Medical, of Wixom, Mich.
Researchers found no significant difference in the frequency or severity of adverse events (AEs) or serious AEs between the groups. No case of anaphylaxis or hypersensitivity occurred in the SFP recipients.
All FDA approved IV iron products for the treatment of iron deficiency anemia are iron-carbohydrate complexes, and it is the carbohydrate moiety that triggers the anaphylactoid or hypersensitivity reactions, explained Ajay Gupta, MD, Chief Scientific Officer for Rockwell.
SFP does not contain carbohydrate, he said, pointing out that not a single anaphylactoid reaction has occurred in patients being given SFP, even after approximately 60,000 human doses administered in clinical trials. With IV iron products, these anaphylactoid reactions do occur, and in one called ferumoxytol, patients have to remain under observation for at least 30 minutes after administration, leading to significant inconvenience and restrictions as to where the drug can be given.
“This successful CRUISE-1 study data confirm our belief that SFP is an extremely safe drug that consistently maintains hemoglobin and that can effectively replace the general need for IV iron administration in dialysis patients,” Dr. Gupta said.
SFP is a unique iron compound that is administered to HD patients via dialysate, replacing the 5-7 mg of iron lost during a dialysis treatment, according to Rockwell. SFP is introduced into the sodium bicarbonate concentrate that subsequently is mixed into dialysate. Once in the dialysate, SFP crosses the dialyzer membrane and enters the bloodstream where it immediately binds to transferrin and is delivered to the bone marrow, similar to the way dietary iron is processed in the human body. This is in contrast to IV iron products indicated for the treatment of iron-deficiency anemia. IV iron is sequestered in the liver due to the anemia of inflammation, before releasing gradually into the bloodstream, Dr. Gupta explained.