A randomized controlled trial of oral versus intravenous iron in chronic kidney disease

Rajiv Agarwal, Adel R. Rizkala, Bahar Bastani, Marwan O. Kaskas, David J. Leehey, Anatole Besarab

Research output: Contribution to journalArticlepeer-review

86 Scopus citations


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 (≥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 × 4 or ferrous sulfate (oral iron) 325 mg t.i.d. × 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.

Original languageEnglish (US)
Pages (from-to)445-454
Number of pages10
JournalAmerican journal of nephrology
Issue number5
StatePublished - Dec 2006


  • Chronic kidney disease
  • Iron supplementation, intravenous versus oral

ASJC Scopus subject areas

  • Nephrology

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