Ferric Pyrophosphate Citrate (Triferic), a novel therapy that treats anemia of inflammation and overcomes functional iron deficiency

12^th Annual Conference on Nephrology & Urology

JULY 06-07, 2017 KUALA LUMPUR, MALAYSIA

Ajay Gupta and Raymond D Pratt

University of California, USA
Rockwell Medical, Inc., USA

Scientific Tracks Abstracts: J Nephrol Ther

Abstract :

Ferric Pyrophosphate Citrate (FPC) is a novel, highly soluble iron salt for parenteral delivery via hemodialysis solution. FPC donates iron directly and rapidly to transferrin, avoiding iron sequestration in the reticuloendothelial system. Randomized, placebo-controlled clinical trials in chronic hemodialysis (CKD 5HD) patients have demonstrated that FPC delivery by hemodialysis can maintain iron balance by replacing regular iron losses, while reducing ESA use and maintaining hemoglobin (Hgb). In the double-blind PRIME study, 104 iron replete (serum ferritin, 200 1000 �¼g/L) CKD 5HD patients received FPC or placebo for 36 weeks. The ESA dose was titrated to maintain Hgb in the target range; intravenous (IV) iron was administered for serum ferritin <200 �¼g/L. Prescribed ESA and IV iron doses were reduced by 35% (p=0.045) and 45% (p=0.028), respectively, in the FPC group, without increases in levels of serum ferritin, hepcidin or markers of oxidative stress/ inflammation. In two single blind phase 3 studies (CRUISE), iron replete CKD 5HD patients received FPC (N=299) or placebo (N=300) for 48 weeks; changes in ESA and IV/oral iron doses were prohibited. Hgb was maintained at baseline levels in FPC treated patients in both studies, whereas placebo treated patients developed iron restricted erythropoiesis. Mean change in Hgb from baseline to end of treatment was 3.6 g/L lower for placebo than for FPC (p=0.011). The safety profile of FPC was similar to placebo, with no anaphylaxis. No increases in incidence of intradialytic hypotension, cardiovascular events, or infections were observed with FPC compared with placebo. FPC is effective in treating functional iron deficiency in states of inflammation, including CKD 5HD.

Biography :

Ajay Gupta received his MBBS degree and completed his residency in internal medicine at the All India Institute of Medical Sciences (New Delhi). He is currently an Adjunct Associate Professor of Medicine at the University of California at Irvine and Chief Scientific Officer at Rockwell Medical, Inc. He is the inventor of dialysate iron therapy using FPC, as well as the inventor of IV iron therapy using slow continuous infusion of FPC. He has published more than 40 papers in reputed journals.

Email: ajayg1@uci.edu