title: Effects of Ferric Citrate in Patients with Nondialysis-Dependent CKD and Iron Deficiency Anemia.
abstract: Iron deficiency anemia is common and consequential in nondialysis-dependent CKD (NDD-CKD). Efficacy and tolerability of conventional oral iron supplements are mixed; intravenous iron administration associates with finite but important risks. We conducted a randomized double-blind clinical trial in adults with NDD-CKD and iron deficiency anemia to compare the safety and efficacy of oral ferric citrate (n=117) and placebo (n=115). The primary end point was the proportion of patients who achieved a ≥1.0 g/dl increase in hemoglobin at any time during a 16-week randomized period. Patients who completed the 16-week period could also participate in an 8-week open-label extension period. Significantly more patients randomized to ferric citrate achieved the primary end point (61 [52.1%] versus 22 [19.1%] with placebo;P<0.001). All secondary end points reached statistical significance in the ferric citrate group, including the mean relative change in hemoglobin (0.84 g/dl; 95% confidence interval, 0.58 to 1.10 g/dl;P<0.001) and the proportion of patients who achieved a sustained increase in hemoglobin (≥0.75 g/dl over any 4-week period during the randomized trial; 57 [48.7%] versus 17 [14.8%] with placebo;P<0.001). Rates of serious adverse events were similar in the ferric citrate (12.0%) and placebo groups (11.2%). Gastrointestinal disorders were the most common adverse events, with diarrhea reported in 24 (20.5%) and 19 (16.4%) and constipation in 22 (18.8%) and 15 (12.9%) patients treated with ferric citrate and placebo, respectively. Overall, in patients with NDD-CKD, we found oral ferric citrate to be a safe and efficacious treatment for iron deficiency anemia.
authors.affiliation: Division of Nephrology, Department of Medicine, Hofstra Northwell School of Medicine, Mineola, New York.
authors.forename: Steven
authors.initials: S
authors.lastname: Fishbane
authors.affiliation: Denver Nephrology, Denver, Colorado.
authors.forename: Geoffrey A
authors.initials: GA
authors.lastname: Block
authors.affiliation: Keryx Biopharmaceuticals Inc., Boston, Massachusetts.
authors.forename: Lisa
authors.initials: L
authors.lastname: Loram
authors.affiliation: Keryx Biopharmaceuticals Inc., Boston, Massachusetts.
authors.forename: John
authors.initials: J
authors.lastname: Neylan
authors.affiliation: Renal Associates Professional Association, San Antonio, Texas; and.
authors.forename: Pablo E
authors.initials: PE
authors.lastname: Pergola
authors.affiliation: Keryx Biopharmaceuticals Inc., Boston, Massachusetts.
authors.forename: Katrin
authors.initials: K
authors.lastname: Uhlig
authors.affiliation: Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Stanford, California gchertow@stanford.edu.
authors.forename: Glenn M
authors.initials: GM
authors.lastname: Chertow
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018798:Anemia, Iron-Deficiency / Q000150:complications* / Q000188:drug therapy*; D004311:Double-Blind Method; D005260:Female; D005290:Ferric Compounds / Q000627:therapeutic use*; D006801:Humans; D008297:Male; D008875:Middle Aged; D051436:Renal Insufficiency, Chronic / Q000150:complications*
chemical_list: D005290:Ferric Compounds; C025314:ferric citrate
keywords: anemia; blood transfusion; clinical trial; hemoglobin; iron deficiency; renal dialysis