A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD

Wyck, David B. Van; Roppolo, Michael; Martínez, Carlos Orlando Alfaro; Mazey, Richard M.; McMurray, Stephen

doi:10.1111/j.1523-1755.2005.00758.x

Cited by 202 publications

(169 citation statements)

References 14 publications

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“…Compared with baseline, 2 weeks after intravenous Fe, there was an 11-fold increase in serum ferritin and a 2-fold increase in TSAT. However, these changes are not expected to reflect Fe overload, because changes in Fe indicators may take up to 14 days to reach steady state after intravenous Fe (23). At 12 weeks, changes in TSAT and serum ferritin compared with baseline were still significant, although all subjects had TSAT Ͻ50%, and all but one subject had serum ferritin Ͻ500 g/L as recommended by guidelines (4,5).…”

Section: Discussionmentioning

confidence: 92%

Serum Iron Markers Are Inadequate for Guiding Iron Repletion in Chronic Kidney Disease

Ferrari

Kulkarni

Dheda

et al. 2011

Clinical Journal of the American Society of Nephrology

124

128

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Summary Background and objectives Iron (Fe) overload may complicate parenteral Fe therapy used to enhance the efficacy of erythropoietic-stimulating agents in the treatment of anemia of chronic kidney disease. However, serum Fe markers are influenced by inflammation or malignancy and may not accurately reflect the amount of body Fe. Design, setting, participants, & measurements We studied the relationship between parenteral Fe therapy, conventional serum Fe markers, and liver iron concentration (LIC) measured using magnetic resonance R2 relaxometry (FerriScan) in 25 Fe-deficient predialysis chronic kidney disease patients before and 2 and 12 weeks after single high-dose intravenous Fe and in 15 chronic hemodialysis patients with elevated serum ferritin (>500 μg/L). Results In predialysis patients, there was strong dose dependency between the administered Fe dose and changes in LIC at weeks 2 and 12; however, no dose dependency between Fe dose and changes in ferritin or transferrin saturation (TSAT) were observed. In hemodialysis patients, LIC correlated with the cumulative Fe dose and duration of dialysis but not with current ferritin or TSAT. The cumulative Fe dose remained a significant independent predictor of LIC in a multiple regression model. Two dialysis patients who received >6 g parenteral Fe had substantially elevated LIC >130 μmol/g, which is associated with hemochromatosis. Conclusions In Fe-deficient predialysis patients, intravenous Fe therapy is associated with increases in LIC unrelated to changes in conventional Fe markers. In hemodialysis patients, TSAT and ferritin are poor indicators of body Fe load, and some patients have LICs similar to those found in hemochromatosis.

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Section: Discussionmentioning

confidence: 92%

Serum Iron Markers Are Inadequate for Guiding Iron Repletion in Chronic Kidney Disease

Ferrari

Kulkarni

Dheda

et al. 2011

Clinical Journal of the American Society of Nephrology

124

128

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“…These data were confirmed by Charytan et al, 48 who showed the safety of IS in hemodialysis patients, including those intolerant of other parenteral iron products. In a randomized, controlled trial comparing IV IS to oral iron in anemic patients with nondialysisdependent CKD, Van Wyck et al 49 showed that IS, given as 1000 mg in divided doses, was more effective than oral iron. In a study of anemic patients with CKD with absent marrow hemosiderin and high serum ferritins, Gotloib et al 50 showed that IV IS administration, with and without ESAs, resulted in increases in hemoglobin levels and achievement of the target hemoglobin of 12 g/dL.…”

Section: Iron Sucrosementioning

confidence: 99%

Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety

2010

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This section reviews the history, pharmacology, administration, efficacy, and toxicity of intravenous iron. Intravenous iron offers advantages over oral iron for the treatment of iron deficiency anemia across a wide range of disease states associated with absolute and functional iron deficiency. However, there remain concerns about the acute safety profiles of the available preparations and the potential for long-term toxicity with their repeated administration. Seven intravenous iron formulations are available. Confusion concerning the relative toxicities of the different formulations abounds. The similarities and differences are discussed. Iron repletion has been associated with adverse outcomes in infections. The relationship, if any, between intravenous iron administration and infections is reviewed. The potential advantages of total dose infusion (TDI), complete repletion in a single setting, are highlighted. A new paradigm for iron replacement therapy in iron deficiency anemia is presented.

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“…18 The effective use of oral iron therapy may be limited in patients with CKD due to insufficient intestinal absorption and gastrointestinal complaints that may reduce patient compliance with treatment. 22 Three of the four published randomized controlled trials that examined the efficacy of treatment with IV and oral iron in anemic, ND-CKD patients indicated that IV iron was more efficacious than oral iron, 23,24,25 whereas a fourth showed no added benefit from IV iron. 26 Taken together, these studies A n estimated 26 million adults in the United States have chronic kidney disease (CKD).…”

Section: Methods: This Was a Retrospective Cohort Analysis Using 2006mentioning

confidence: 99%

Clinical and Economic Outcomes in Medicare Beneficiaries with Stage 3 or Stage 4 Chronic Kidney Disease and Anemia: The Role of Intravenous Iron Therapy

Knight

Ryan²,

Schaefer³

et al. 2010

JMCP

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• Anemia is a common occurrence in patients with chronic kidney disease (CKD), with reported prevalence rates of 9%-64% depending on CKD stage and definition of anemia and is associated with increased morbidity and mortality. In a sample of patients with incident CKD, Thorp et al. (2009) [IV]) in CKD patients with anemia (defined as hematocrit less than 33% in women of childbearing age or less than 37% in men and postmenopausal women) in whom therapy with an erythropoiesisstimulating agent (ESA) does not raise the hematocrit above the threshold levels because iron levels are too low. Iron deficiency is defined in the NIDDK guidelines as a ferritin score less than 100 micrograms (mcg) per liter and a transferrin saturation (TSAT) score less than 20%.• While previous research has demonstrated the effectiveness of IV iron therapy in correcting anemia in some patients with CKD, the clinical and economic outcomes associated with IV iron therapy compared with other treatments including ESA in routine clinical practice are unknown. What is already known about this subjectABSTRACT BACKGROUND: Anemia in patients with chronic kidney disease (CKD) is associated with increased morbidity and mortality, decreased quality of life, and substantial health care costs. Iron therapy is recommended, usually in combination with an erythropoiesis-stimulating agent (ESA), in many CKD patients with anemia and low iron levels to raise hemoglobin levels to a range of 10 to 12 grams per deciliter; iron deficiency is defined by a ferritin score less than 100 micrograms (mcg) per liter and transferrin saturation (TSAT) less than 20%.

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A randomized, controlled trial comparing IV iron sucrose to oral iron in anemic patients with nondialysis-dependent CKD

Abstract: IV iron administration using 1000 mg iron sucrose in divided doses is superior to oral iron therapy in the management of ND-CKD patients with anemia and low iron indices.

Cited by 202 publications

References 14 publications

Serum Iron Markers Are Inadequate for Guiding Iron Repletion in Chronic Kidney Disease

Serum Iron Markers Are Inadequate for Guiding Iron Repletion in Chronic Kidney Disease

Clinical Use of Intravenous Iron: Administration, Efficacy, and Safety

Clinical and Economic Outcomes in Medicare Beneficiaries with Stage 3 or Stage 4 Chronic Kidney Disease and Anemia: The Role of Intravenous Iron Therapy

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