Table 1 Summary of IV iron studies in patients with iron deficiency anemia and CKD receiving HD
Studya, b | Patients | N | HD patients, n | Treatments | Duration | Primary endpoint |
|---|---|---|---|---|---|---|
Active comparator | ||||||
Anirban et al. 2008 [24] | CKD-HD, CKD-CAPD, and CKD-NDD | 339 | 210 | IV iron dextran IV sodium ferric gluconate complex IV iron sucrose | 48 h | Incidence of serious/nonserious adverse drug events |
Besarab et al. 2000 [25] | CKD-HD | 42 | 42 | IV iron dextran (patients assigned to 1 of 2 dosing regimens) | 6 months | Determine if maintenance iron protocol that increased TSAT levels from 20–30% to 30–50% increased erythropoiesis and reduced rHuEPO doses needed to maintain Hb of 9.5–12.0 g/dL (95.0–120.0 g/L) vs. protocol targeting TSAT levels of 20–30% |
Charytan et al. 2013 [26] | CKD-HD and CKD-NDD | 254 | 50 | IV ferric carboxymaltose Oral, IV, or no iron (standard medical care) | 30 days | Safety of the maximum administered dose of ferric carboxymaltose vs. standard medical care |
Goldstein et al. 2013 [27] | CKD-HD, CKD-NDD, or CKD-PD | 145 | 91 | IV iron sucrose (patients assigned to 1 of 3 doses by weight) | 3 months | Composite of Hb ≥10.5–14.0 g/dL (≥105.0–140.0 g/L), inclusive; TSAT ≥20–50%, inclusive; and stable ESA dosing (± 25% of baseline dose) |
Kosch et al. 2001 [28] | CKD-HD | 59 | 59 | IV ferric gluconate (Ferrlecit) IV iron sucrose | 6 months | Differences in Hb, TSAT, ferritin, % hypochromic red blood cells, and rHuEpo dose requirements |
Macdougall et al. 2014 [17] | CKD-HD and CKD-NDD | 162 | 70 | IV ferumoxytol IV iron sucrose | 7 weeks | Descriptive review of adverse effects; change in Hb from Baseline to Day 35 |
Sav et al. 2007 [29] | CKD-HD, CKD-CAPD, and CKD-NDD | 60 | 60 | IV iron dextran IV iron sucrose | 48 hourss | Adverse reactions immediately (i.e., within 30 min) or up to 48 h after infusion |
Sheashaa et al. 2005 [30] | CKD-HD | 48 | 48 | IV iron saccharate complex IV sodium ferric gluconate complex | 6 months | Change in serum iron, serum ferritin, TSAT, Hb, and hematocrit |
Warady et al. 2005 [31] | CKD-HD Pediatric | 66 | 66 | IV sodium ferric gluconate complex 1.5 mg/kg IV sodium ferric gluconate complex 3.0 mg/kg | 8-dose treatment with each dialysis + 4 weeks | Mean changes in Hb, hematocrit, TSAT, serum ferritin, and reticulocyte Hb content values from Baseline to 2 weeks after dosing cessation |