- Rockwell Medical Inc RMTI has announced the publication of results in the Journal of Bioequivalence & Bioavailability from a study evaluating the co-administration of intravenous (IV) Ferric Pyrophosphate Citrate (FPC, Triferic) with unfractionated heparin (UFH) as an admixture.
- The study demonstrated no clinically relevant drug-drug interaction (DDI) between FPC and UFH on the effects of UFH nor on the ability of FPC to deliver bioavailable iron when these agents are co-administered as a single admixture via an HD-machine syringe pump.
- The trial was conducted to investigate the ability of an FPC/UFH admixture to maintain adequate anticoagulation of the dialyzer circuit and to assess the impact of administration of the admixture on the iron delivery of FPC in patients with Hemodialysis Dependent Chronic Kidney Disease (HDD-CKD).
- The study found that mean anti-Xa activity, activated prothrombin time (aPTT), Thrombin time (TT) concentrations were comparable across all timepoints at baseline and throughout the study.
- The concentration-time profiles for iron and TSAT were the same between the FPC/UFH admixture and FPC/UFH administered by separate routes.
- FPC and UFH were well tolerated with no reported adverse events.
- FPC is FDA-approved used to replace iron to maintain hemoglobin in adult patients with HDD-CKD.
- Price Action: RMTI shares 17.30% at $0.57 during the market session on the last check Wednesday.
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