title: A randomized controlled trial of oral versus intravenous iron in chronic kidney disease.
abstract: BACKGROUND
  It is unknown whether intravenous iron or oral iron repletion alone can correct anemia associated with chronic kidney disease (CKD). We conducted a randomized multicenter controlled trial in adult anemic, iron-deficient non-dialysis CKD (ND-CKD) patients (>or=stage 3) not receiving erythropoiesis-stimulating agents (ESAs).
  
  
  METHODS
  The participants were randomized to receive either a sodium ferric gluconate complex (intravenous iron) 250 mg i.v. weekly x 4 or ferrous sulfate (oral iron) 325 mg t.i.d. x 42 days. Hemoglobin (Hgb), ferritin and transferrin saturation (TSAT) were measured serially, and the Kidney Disease Quality of Life (KDQoL) questionnaire was administered on days 1 and 43. The primary outcome variable was change from baseline (CFB) to endpoint in Hgb values.
  
  
  RESULTS
  Seventy-five patients were analyzed (intravenous iron n = 36, oral iron n = 39). CFB in Hgb was similar in the two groups (intravenous iron 0.4 g/dl vs. oral iron 0.2 g/dl, p = n.s.). However, the increase in Hgb was only significant with intravenous iron (p < 0.01). In comparison to oral iron, intravenous iron achieved greater improvements in ferritin (232.0 +/- 160.8 vs. 55.9 +/- 236.2 ng/ml, p < 0.001) and TSAT (8.3 +/- 7.5 vs. 2.9 +/- 8.8%, p = 0.007). Intravenous iron caused greater improvements in KDQoL scores than oral iron (p < 0.05). The most common side effect reported with intravenous iron was hypotension, while constipation was more common with oral iron.
  
  
  CONCLUSIONS
  Oral and intravenous iron similarly increase Hgb in anemic iron-depleted ND-CKD patients not receiving ESAs. Although in comparison to oral iron, intravenous iron may result in a more rapid repletion of iron stores and greater improvement in quality of life, it exposes the patients to a greater risk of adverse effects and increases inconvenience and cost.
authors.affiliation: Indiana University School of Medicine, Richard L. Roudebush VA Medical Center, Indianapolis, IN 46202, USA. ragarwal@iupui.edu
authors.forename: Rajiv
authors.initials: R
authors.lastname: Agarwal
authors.forename: Adel R
authors.initials: AR
authors.lastname: Rizkala
authors.forename: Bahar
authors.initials: B
authors.lastname: Bastani
authors.forename: Marwan O
authors.initials: MO
authors.lastname: Kaskas
authors.forename: David J
authors.initials: DJ
authors.lastname: Leehey
authors.forename: Anatole
authors.initials: A
authors.lastname: Besarab
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D002908:Chronic Disease; D004920:Erythropoiesis / Q000187:drug effects; D005260:Female; D005290:Ferric Compounds / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006397:Hematinics / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D007674:Kidney Diseases / Q000097:blood / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D012307:Risk Factors
chemical_list: D005290:Ferric Compounds; D006397:Hematinics; C035552:ferric gluconate