A randomized trial of intravenous and oral iron in chronic kidney disease

Rajiv Agarwal, John W. Kusek, Maria K. Pappas

Research output: Contribution to journalArticle

80 Citations (Scopus)

Abstract

Although iron is commonly used to correct iron deficiency anemia (IDA) in chronic kidney disease (CKD), its effect on kidney function is unclear. To assess this, we randomly assigned patients with stage 3 and 4 CKD and IDA to either open-label oral ferrous sulfate (69 patients to 325 mg three times daily for 8 weeks) or intravenous iron sucrose (67 patients to 200 mg every 2 weeks, total 1 g). The primary outcome was the between-group difference in slope of measured glomerular filtration rate (mGFR) change over two years. The trial was terminated early on the recommendation of an independent data and safety monitoring board based on little chance of finding differences in mGFR slopes, but a higher risk of serious adverse events in the intravenous iron treatment group. mGFR declined similarly over two years in both treatment groups (oral -3.6 ml/min per 1.73 m 2, intravenous -4.0 ml/min per 1.73 m 2, between-group difference -0.35 ml/min per 1.73 m 2; 95% confidence interval -2.9 to 2.3). There were 36 serious cardiovascular events among 19 participants assigned to the oral iron treatment group and 55 events among 17 participants of the intravenous iron group (adjusted incidence rate ratio 2.51 (1.56-4.04)). Infections resulting in hospitalizations had a significant adjusted incidence rate ratio of 2.12 (1.24-3.64). Thus, among non-dialyzed patients with CKD and IDA, intravenous iron therapy is associated with an increased risk of serious adverse events, including those from cardiovascular causes and infectious diseases.

Original languageEnglish (US)
Pages (from-to)905-914
Number of pages10
JournalKidney International
Volume88
Issue number4
DOIs
StatePublished - Oct 3 2015

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Chronic Renal Insufficiency
Iron
Iron-Deficiency Anemias
Glomerular Filtration Rate
saccharated ferric oxide
ferrous sulfate
Clinical Trials Data Monitoring Committees
Incidence
Therapeutics
Communicable Diseases
Hospitalization
Cardiovascular Diseases
Confidence Intervals
Kidney
Infection

Keywords

  • adverse effects
  • anemia
  • chronic kidney disease
  • iron
  • randomized controlled trial

ASJC Scopus subject areas

  • Nephrology

Cite this

A randomized trial of intravenous and oral iron in chronic kidney disease. / Agarwal, Rajiv; Kusek, John W.; Pappas, Maria K.

In: Kidney International, Vol. 88, No. 4, 03.10.2015, p. 905-914.

Research output: Contribution to journalArticle

Agarwal, Rajiv ; Kusek, John W. ; Pappas, Maria K. / A randomized trial of intravenous and oral iron in chronic kidney disease. In: Kidney International. 2015 ; Vol. 88, No. 4. pp. 905-914.
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