Iron Sucrose in Stage 3/4 Kidney Disease

2014-08-27 03:49:38 | BioPortfolio


One of the complications of late stage kidney disease is the development of a low red blood cell count (anaemia/low haemoglobin concentration). The Australian Commonwealth government limits funding of medications (called erythropoietic stimulating agents) to those patients who have already developed anaemia.

There is evidence supporting the beneficial effects of maintaining a higher haemoglobin in these patients. Higher haemoglobin can delay the onset of dialysis and reduce the development of heart enlargement. However, the administration of erythropoietic stimulating agents is not without risk, including a high financial burden, worsening of high blood pressure and a rare complication called pure red cell aplasia.

Previous studies have shown that patients with chronic kidney disease require additional iron to maintain the production of red blood cells. Thus it would be timely to determine if the administration of iron sucrose to these patients can maintain a near normal haemoglobin concentration, without the need to start an erythropoietic stimulating agent and possibly delaying dialysis.

Study Hypothesis: That administration of iron sucrose is superior to standard care in the prevention of anaemia in patients with stage 3 /4 kidney disease.


Eligible patients will be approached. Those who agree to partake in the study will, after enrolment (including informed consent), be randomized to one of 2 groups.

Group A: To receive intravenous iron sucrose to maintain supra-physiological measures of iron status ) Group A will be targeted to have ferritin levels between 300 and 500µg/L and/or a transferrin saturation of between 25 and 50%. Between 100 and 200mg of intravenous iron sucrose will be administered by slow bolus injection one- to two-monthly to achieve these levels.

Oral iron will not be used routinely in this group.

Group B: Will have oral iron therapy if required to maintain ferritin levels between 100 and 150µg/L and/or transferrin saturations >20% but <25%. Patients in Group B who are unable to tolerate oral iron will be administered iron sucrose if necessary to maintain acceptable iron levels.

Patients in Group B will therefore differ from those in Group A (a) through the routine use of iron sucrose and (b) through the maintenance of different ferritin and transferrin saturation levels.

Study Design

Allocation: Randomized, Control: Active Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Kidney Failure


Iron sucrose


Central Coast Health
New South Wales


Active, not recruiting


Melbourne Health

Results (where available)

View Results


Published on BioPortfolio: 2014-08-27T03:49:38-0400

Clinical Trials [1706 Associated Clinical Trials listed on BioPortfolio]

Safety Efficacy of Iron Sucrose in Children

Comparison of three potential iron sucrose maintenance regimens in pediatric chronic kidney disease patients

Intravenous Iron in Patients With Anemia of Chronic Kidney Disease

The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.

Heme Iron Polypeptide for Iron Deficiency Anemia in Chronic Renal Failure

The purpose of this study is to determine if oral Heme Iron Polypeptide is as effective as IV iron sucrose in the treatment of iron-deficiency anemia for patients with chronic kidney disea...

IDA-01 A Randomised, Open-Label, Comparative Study of Intravenous Iron Isomaltoside 1000 (Monofer®) and Iron Sucrose

The purpose of the trial is to evaluate and compare the effect of iron isomaltoside 1000 to iron sucrose in its ability to increase haemoglobin (Hb) in subjects with IDA when oral iron pre...

Comparison Between Effects of Two Iron Preparations on Protein in the Urine

This study will compare the effects of sodium ferric gluconate complex and iron sucrose on urine concentrations of various chemicals including protein

PubMed Articles [7689 Associated PubMed Articles listed on BioPortfolio]

Comparative Short-term Safety of Sodium Ferric Gluconate Versus Iron Sucrose in Hemodialysis Patients.

Despite different pharmacologic properties, little is known about the comparative safety of sodium ferric gluconate versus iron sucrose in hemodialysis patients.

A capillary electrophoresis method for speciation of iron (II) and iron (III) in pharmaceuticals by dual pre-capillary complexation.

Pharmaceutical iron sucrose is an iron (III) replacement for the treatment of iron deficiency anemia in patients with chronic kidney disease. The drug product (injection) is a colloidal solution of fe...

Is iron important in heart failure?

Iron deficiency is a frequent comorbidity in a patient with chronic heart failure, and it associates with a worse pro-gnosis of that patient. Mainly worse quality of life and more rehospitalizations a...

Iron Status and Inflammation in Early Stages of Chronic Kidney Disease.

One of the most common causes of anemia of chronic disease (ACD) is chronic kidney disease. The main pathomechanism responsible for ACD is subclinical inflammation. The key element involved in iron me...

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

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 sta...

Medical and Biotech [MESH] Definitions

A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal failure, either acute (KIDNEY FAILURE, ACUTE) or chronic (KIDNEY FAILURE, CHRONIC), requires HEMODIALYSIS.

A complication of kidney diseases characterized by cell death involving KIDNEY PAPILLA in the KIDNEY MEDULLA. Damages to this area may hinder the kidney to concentrate urine resulting in POLYURIA. Sloughed off necrotic tissue may block KIDNEY PELVIS or URETER. Necrosis of multiple renal papillae can lead to KIDNEY FAILURE.

The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.

Iron or iron compounds used in foods or as food. Dietary iron is important in oxygen transport and the synthesis of the iron-porphyrin proteins hemoglobin, myoglobin, cytochromes, and cytochrome oxidase. Insufficient amounts of dietary iron can lead to iron-deficiency anemia.

Acute kidney failure resulting from destruction of EPITHELIAL CELLS of the KIDNEY TUBULES. It is commonly attributed to exposure to toxic agents or renal ISCHEMIA following severe TRAUMA.

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