The TREAT involved 4038 patients with anaemia, chronic kidney disease and type 2 diabetes . Thanks for visiting Hematology Advisor. FC is an oral iron repletion agent approved to treat IDA in the NDD-CKD patient population; it has a favorable safety and efficacy profile and may spare IV iron and ESA use, and possibly delay the transition to dialysis. here. Now with TREAT, a much larger, better executed and more persuasive study than either of the previous ones, we can reach conclusions with greater confidence. One group was intended to be a placebo arm, with Hb levels allowed to fall to around 9 g/dL, but with pre-specified rescue therapy if needed to restore Hb to above 9 g/dL. Br J Haematol. Sucrosomial((R)) iron: a new generation iron for improving oral supplementation. Shield Therapeutics plc; October 1, 2018. https://www.shieldtherapeutics.com/rns_news/submission-of-an-nda-for-feraccru-with-the-fda/. Importantly, transfusion requirements were halved in the treatment arm (but were still needed in around 20% of the active ESA-treated patients). Iron metabolism: interactions with normal and disordered erythropoiesis. When CREATE and CHOIR were published in November 2006, the FDA issued a ‘black-box’ warning for ESAs and were criticized by many for doing so. Image, Download Hi-res Sucrosomial((R)) iron supplementation in mice: effects on blood parameters, hepcidin, and inflammation. When evaluating the benefits and risks of iron repletion therapy, IV iron sparing and ESA-sparing strategies are important to consider. Transfusion avoidance is important, reducing the risk of iron overload, infection and allosensitization, and is shown well in TREAT , though ESA use does not abolish the need for blood transfusion. Ferric maltol was evaluated in a 12-week open-label, uncontrolled proof-of-concept study to determine the tolerability and efficacy in patients with IDA with documented intolerance to ferrous sulfate (. Abbreviations: ADR, adverse drug reaction; AE, adverse event; BL, baseline; CKD, chronic kidney disease; DD-CKD, dialysis-dependent CKD; ESRD, end-stage renal disease; FC, ferric citrate; FCH, ferric citrate hydrate; GI, gastrointestinal; Hb, hemoglobin; IDA, iron deficiency anemia; IV, intravenous; NDD-CKD, non-dialysis-dependent CKD; TSAT, transferrin saturation; TEAE, treatment emergent adverse events. This trial, with its placebo design, was wisely allowed to be continued even after the results of CREATE and CHOIR were reported in 2006, as it had already been criticized by some for being unethical by exposing patients to the absence of epoetin, while other commentators were just as critical of the design for potentially ‘over-treating’ other patients. IV iron can be administered in larger doses by circumventing tolerability issues associated with oral iron preparations. Follow-up 30 days, Mean change (±SD) in TSAT: 2.55 ± 15.26% vs 5.80 ± 13.84%, Proportion of patients achieving an increase in Hb of ≥1.0 g/dL: 19.1% vs 30.4%, IV iron isomaltoside 1000 vs IV iron sucrose, Patients on hemodialysis for ≥90 days, Hb between 9.5 and 12.5 g/dL, ferritin <800 ng/mL, TSAT <35%, ESAs at stable dose for prior 4 weeks, There was an increase in serum iron and TSAT concentration from baseline to week 6 in both groups; however, no statistically significant changes were observed between the treatment groups, Majority of patients in either group were able to maintain Hb between 9.5 and 12.5 g/dL at week 6, Phase 2 open-label study of safety and tolerability of FC as a phosphate binder, Patients on hemodialysis (3 times a week), serum phosphorus ≥2.5 mg/dL (cohort I) or ≥3.5 mg/dL (cohort II), ferritin <1000 mg/L; TSAT <50%, Cohort I: 4.5 g/d; cohort II: 6 g/d (375 mg capsules of FC), Mean change (range) in TSAT: 5.35% (–20.5 to 40.5) (, 45% of patients received IV iron during the treatment period; there was no significant difference in serum iron and TSAT from BL to FU, Phase 3 open-label dose titration long-term study of FCH as a phosphate binder, Patients on hemodialysis (3 times a week), serum phosphate 3.5-10.0 mg/dL for patients receiving medication for hyperphosphatemia, and 6.1-10.0 mg/dL for patients not on any treatment, 1.5 g/d (6 tablets/d); titrated up to 6.0 g/day (24 tablets/d) according to [phosphate], Mean weekly ESA dose reduced by 25% from BL (4541 IU/wk) to end-of-treatment (3412 IU/wk), Phase 3 open-label dose-adjusted study of FCH as a phosphate binder, Patients on peritoneal dialysis for ≥12 weeks who had discontinued phosphate binders with serum phosphate between 5.6 and 10.0 mg/dL, Dose adjusted between 1.5 and 6.0 g of FCH a day according to serum phosphate, Median (25th, 75th percentile ferritin at BL and FU, Phase 3 trial of FC as a phosphate binder in patients with ESRD, on hemodialysis or peritoneal dialysis, Serum ferritin <1000 ng/mL, TSAT <50%, serum phosphorus ≥2.5 and ≤8.0 mg/dL at screening, 52-week active control period followed by 4-week open-label placebo control period (at 52 weeks, patients re-randomized to FC or placebo), Phase 3 trial of FC in patients with ESRD on maintenance hemodialysis, Patients on maintenance hemodialysis (3 times a week), 4 g (840 mg elemental ferric iron) of FC or 6 g (1260 mg elemental ferric iron) per day of FC or placebo, Median (IQR) change in ferritin from BL to FU, Hb from BL to week 8 was not different between the 3 groups, Phase 3, double blind, placebo-controlled study of FCH vs placebo in NDD-CKD, Serum phosphate ≥5.0 and <8.0 mg/dL during screening period, 1.5 g/day FCH after a meal vs placebo for 12 weeks, Although there was no significant difference between groups, Hb increased from 10.3 to 10.7 g/dL (, Phase 2 randomized study of FC vs placebo in patients with non-dialysis-dependent CKD, FC initiated at a dose of 3 × 210 mg/d elemental iron given after meals, dose adjusted based on serum phosphate, No ESAs within 4 weeks or IV iron within 8 weeks, Phase 3 randomized study of FC vs placebo in patients with non-dialysis-dependent CKD and IDA, 16 weeks (and 8-week open-label extension period).
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