Effect Of Intravenous Iron Sucrose Research Articles

A pilot study on effect of intravenous iron sucrose on oxidative stress and antioxidant status of pregnant women with iron deficiency anemia

Objectives: Iron deficiency anemia (IDA) is the most common nutritional deficiency among pregnant women in India. Iron can be supplemented orally or intravenously to treat IDA. Intravenous supplementation of iron can be risky as there is more possibility for the production of free iron in circulation. The role of free iron in the generation of free radicals and thereby oxidative stress is well known. The present study tends to evaluate oxidative stress and antioxidant status of intravenous iron sucrose treated pregnant women. Materials and Methods: This prospective study was conducted in ACS Medical College and Hospital, Chennai. Twenty pregnant women with moderate IDA (Hb: 7–9.9 g/dl) were included in the present study. Blood samples were collected before and after the treatment with intravenous iron sucrose to measure antioxidants such as reduced glutathione, catalase and superoxide dismutase, and lipid peroxidation marker such as malondialdehyde. Results: In the present study, plasma malondialdehyde levels were increased significantly after the treatment with intravenous iron sucrose. No significant alterations were observed in the levels of reduced glutathione and activities of catalase and superoxide dismutase. Conclusion: In the present study, intravenous iron sucrose infusion was associated with oxidative stress as evidenced by increased lipid peroxidation in antenatal women with IDA. Hence, treatment with antioxidants during iron infusions can be considered.

Effect of intravenous iron on functional outcomes in hip fracture: a randomised controlled trial.

to determine the safety and effect of intravenous iron sucrose on functional outcomes, delirium, nosocomial infections and transfusion requirements in older patients with hip fracture. single-centre randomised, double-blind, placebo-controlled clinical trial. orthogeriatric share care service at an academic tertiary care hospital. A total of 253 patients were recruited: 126 patients were assigned to intravenous iron and 127 to placebo. on days 1, 3 and 5 after admission, the iron group received 200mg Venofer® (iron sucrose) in 100ml saline and the placebo group 100ml saline. The primary outcome was absolute functional gain, considered as Barthel index (BI) at discharge minus BI on admission. Secondary outcomes included incidence of postoperative delirium according to the confusion assessment method, proportion of patients recovering prior functional status at 3months, postoperative transfusion requirements, haemoglobin at 3months, incidence of nosocomial infections and safety. the median participant age was 87 (interquartile range, 82.5-91.5) years. Most patients were female (72.7%), and the median previous BI was 81(59-95). No significant effect of intravenous iron was observed for the primary outcome: the median AFG score was 17.1 points (4.8-23.3) in the intravenous iron group and 16 points (6-26) in the placebo group (P = 0.369). No significant treatment effects were observed for other functional outcomes or secondary end points. while we found no impact of intravenous iron sucrose on functional recovery, incidence of postoperative delirium, transfusion requirements, haemoglobin at 3months, mortality and nosocomial infections rates in older patients with hip fracture, we did find that the intervention was safe.

Safety and effectiveness of intravenous iron sucrose versus standard oral iron therapy in pregnant women with moderate-to-severe anaemia in India: a multicentre, open-label, phase 3, randomised, controlled trial

Intravenous iron sucrose is a promising therapy for increasing haemoglobin concentration; however, its effect on clinical outcomes in pregnancy is not yet established. We aimed to assess the safety and clinical effectiveness of intravenous iron sucrose (intervention) versus standard oral iron (control) therapy in the treatment of women with moderate-to-severe iron deficiency anaemia in pregnancy. We did a multicentre, open-label, phase 3, randomised, controlled trial at four government medical colleges in India. Pregnant women, aged 18 years or older, at 20-28 weeks of gestation with a haemoglobin concentration of 5-8 g/dL, or at 29-32 weeks of gestation with a haemoglobin concentration of 5-9 g/dL, were randomly assigned (1:1) to receive intravenous iron sucrose (dose was calculated using a formula based on bodyweight and haemoglobin deficit) or standard oral iron therapy (100 mg elemental iron twice daily). Logistic regression was used to compare the primary maternal composite outcome consisting of potentially life-threatening conditions during peripartum and postpartum periods (postpartum haemorrhage, the need for blood transfusion during and after delivery, puerperal sepsis, shock, prolonged hospital stay [>3 days following vaginal delivery and >7 days after lower segment caesarean section], and intensive care unit admission or referral to higher centres) adjusted for site and severity of anaemia. The primary outcome was analysed in a modified intention-to-treat population, which excluded participants who refused to participate after randomisation, those who were lost to follow-up, and those whose outcome data were missing. Safety was assessed in both modified intention-to-treat and as-treated populations. The data safety monitoring board recommended stopping the trial after the first interim analysis because of futility (conditional power 1·14% under the null effects, 3·0% under the continued effects, and 44·83% under hypothesised effects). This trial is registered with the Clinical Trial Registry of India, CTRI/2012/05/002626. Between Jan 31, 2014, and July 31, 2017, 2018 women were enrolled, and 999 were randomly assigned to the intravenous iron sucrose group and 1019 to the standard therapy group. The primary maternal composite outcome was reported in 89 (9%) of 958 patients in the intravenous iron sucrose group and in 95 (10%) of 976 patients in the standard therapy group (adjusted odds ratio 0·95, 95% CI 0·70-1·29). 16 (2%) of 958 women in the intravenous iron sucrose group and 13 (1%) of 976 women in the standard therapy group had serious maternal adverse events. Serious fetal and neonatal adverse events were reported by 39 (4%) of 961 women in the intravenous iron sucrose group and 45 (5%) of 982 women in the standard therapy group. At 6 weeks post-randomisation, minor side-effects were reported by 117 (16%) of 737 women in the intravenous iron sucrose group versus 155 (21%) of 721 women in the standard therapy group. None of the serious adverse events was found to be related to the trial procedures or the interventions as per the causality assessment made by the trial investigators, ethics committees, and regulatory body. The study was stopped due to futility. There is insufficient evidence to show the effectiveness of intravenous iron sucrose in reducing clinical outcomes compared with standard oral iron therapy in pregnant women with moderate-to-severe anaemia. WHO, India.

Effect of intravenous iron sucrose on hemoglobin level, when administered in a standard dose, to anemic pregnant women in rural Northern India.

Effect of intravenous iron sucrose on hemoglobin level, when administered in a standard dose, to anemic pregnant women in rural Northern India.

Effect of intravenous iron sucrose on hemoglobin level, when administered in a standard-dose, to anemic pregnant women in rural Northern India.

Introduction:To combat anemia among pregnant women, in Haryana, Northern India, administration of intravenous iron sucrose (IVIS) was initiated in 2014 as a public-health measure. We assessed the effect of IVIS on hemoglobin (Hb) levels among the pregnant anemic women.Methods:Pregnant women identified as moderately or severely anemic (Hb <10.0 g/dL) in the second or third trimester during routine antenatal care were prescribed IVIS in a standard-dose of 400 mg given as 100 mg on alternate days. Neither dose calculation, nor allowance for iron-store, was included in this study. We analyzed the data collected between June 2014 and December 2015, at the two primary-health-centers, on Hb level (by HemoCue method) before start of the therapy (baseline), and 4-week or more after the last infusion (endline).Results:A total of 990 women received IVIS. Both baseline and endline Hg-levels were available for 763 (77%), who were included in the analysis. At baseline, the proportion of moderate and severe anemia was 87.94% and 12.06%, respectively. Mean (standard deviation)-Hb increased from 7.85 g/dL (0.80) at baseline, to 9.62 g/dL (1.30) at endline, with a mean increase of 1.76 g/dL (95% confidence interval 1.67, 1.85). The mean increase in Hb-level for pregnant women who had severe and moderate anemia at baseline was 2.54 g/dL and 1.65 g/dL, respectively. Overall, 15.33% of women achieved normal Hb-level by the time of endline measurement. No serious adverse reactions were reported during the observation period.Conclusion:Mean increase in Hb-level was 1.76 mg/dL. Severely anemic pregnant women had larger increase in Hb-level when compared with pregnant women with moderate anemia.

Intravenous Iron Sucrose Therapy in Iron Deficiency Anemia in Antenatal and Postnatal Patients

Iron deficiency anemia is the most common nutritional deficiency in pregnancy and more common in developing countries which is aggravated due to increased demand and blood loss during delivery. Though there are different methods for treating iron deficiency anemia. Iron sucrose is being used because of its minimal side effects. This study was undertaken to evaluate the response and effect of intravenous iron sucrose given to patient in antenatal and postnatal period with moderate iron deficiency anemia. A hospital based prospective study was conducted 1st Jan 2013-30th Dec 2014 in the department of obstetrics and gynecology Kathmandu Medical College, Teaching Hospital Kathmandu, Nepal. Antenatal and postnatal patients with hemoglobin between 5-9 gm% with diagnosed iron deficiency anemia were included in the study. The aim was to bring her hemoglobin level to 11gm%. All together 37 patients were enrolled out of which two patient were dropped due to allergic reaction and 35 patients were included in study. Iron sucrose therapy is effective in achieving target hemoglobin of 11gm/dl in 80% of patients. It showed that intravenous iron sucrose significantly (P < 0.001) increase hemoglobin level within two weeks of therapy without any major adverse effects. Iron sucrose therapy is safe, effective and well tolerated for the treatment of iron deficiency anemia. Parental iron therapy was effective in increasing hemoglobin, serum ferritin and other hematological parameters in antenatal and postnatal patients with anemia. The treatment will help to reduce the risk of maternal complication during pregnancy and postpartum and its adverse effect to fetus.

Evaluation of effectiveness of intravenous iron sucrose in antenatal patients of iron deficiency anemia

Background: Iron deficiency anaemia (IDA) is the most common nutritional deficiency in pregnancy. Prophylactic oral iron is recommended during pregnancy to meet the increased requirement of iron. In India, more than 50% women become pregnant with low baseline haemoglobin level resulting in high incidence of moderate to severe anaemia in pregnancy where oral iron therapy cannot meet the requirement. This study was undertaken for critical evaluation of iron sucrose in terms of efficacy, safety, and feasibility along with any reduction in blood transfusion rate. Aims & Objective: To evaluate the efficacy of intravenous Iron sucrose in antenatal patients with Iron deficiency anaemia and to study the side effects of intra venous Iron sucrose. Material and Methods: This prospective study was conducted from Nov 2012 to June 2013 at VS General Hospital, Ahmedabad. 60 antenatal patients found to have anaemia having Hb level < 9 gm% were admitted and given intravenous iron sucrose therapy 100mg alternate day after calculating the dose of the iron requirement. Results: In patients having moderate anaemia (Hb 7-9 gm%), the rise in Hb found to be 2.17 ± 0.45 gm% from pre-treatment Hb of 7.88 ± 0.58 gm% to 9.9 ± 0.53 gm%. In patients with severe anaemia (Hb < 7 gm%), the rise in Hb was observed up to 2.73 ± 0.51 (SD) gm% after 1 month of iron sucrose treatment. No major side effects or anaphylactic reactions were noted during the study period. Conclusion: Parenterally administered iron sucrose elevates Hb and restores iron stores earlier and also that intravenous iron administration has led to the reduction in the rate of blood transfusion rate.

English

CONTEXT: AIMS: Comparison between intravenous iron sucrose & oral ferrous fumarate in chronic anaemia due to chronic haemorrhoids. SETTINGS AND DESIGN: METHODS AND MATERIAL: This study was conducted on 30 patients with chronic anaemia with Hb from 4.4 – 8 gm/dl. The patients were randomized into two groups. Group 1 consisted of 15 patients who received 300-600 mg of intravenous iron sucrose every alternate day for 3 days. Group2 consisted of 15 patients & were given 300 mg of ferrous fumarate orally daily for 14 days. Statistical analysis used: RESULTS: After 14 days in group1 the Hb increased by 2.8 gm/dl in comparison to 1 gm/dl in group 2. CONCLUSIONS: The results show that use of intravenous iron sucrose increases Hb level more rapidly than oral therapy in chronic anaemic patients of haemorrhoids without any side effects. KEY-WORDS: Chronic anaemia, iron sucrose, ferrous fumarate. KEY MESSAGES: INTRODUCTION: The prevalence of chronic anaemia in haemorrhoid patients is quite common because of chronic bleeding. This leads to morbidity such as lethargy, tiredness, dizziness. Anaemia is usually due to chronic and excessive bleeding in haemorrhoid patients comparing to haemoglobin formation by body. Blood transfusion is often required for severe cases or oral iron medication is added for increasing haemoglobin along with measures to stop further bleeding. Oral iron can cause some side effects like constipation, which is not good for haemorrhoids, nausea and gastric irritation which effects compliance. Blood transfusion gives quick results but have higher chances of infections like hepatitis B & C, HIV. Due to this intravenous iron therapy has been considered an alternative as now available iron sucrose is very safe and hardly have any side effects. Hence the main aim of this study is to compare effectiveness of intravenous iron sucrose versus oral ferrous fumarate in anaemic patients. Subjects and Methods: The study was randomized & performed at Dept. of surgery in S G T medical college, Gurgaon. The study included 30 patients in the age group of 35-65 years with Hb in range of 4.4-8 gm. The patients were randomized into two groups as per there Hb level. After approval of ethical committee of college and taking consent from patients 15 patients were selected in group 1 and 15 patients were included in group 2. Treatments: Group 1 received 300-600 mg of intravenous iron in two or three divided doses given every alternative day for 3 days. The dose was calculated by formula as Total iron dose in mg = 2.4 x wt x deficit

Receptor for advanced glycation end products (RAGE) in atrial fibrillation

with advanced heart failure. J Am Coll Cardiol 2006;48:2485–9. [9] Okonko DO, Grzeslo A, Witkowski T, et al. Effect of intravenous iron sucrose on exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency: FERRIC-HF: a randomized, controlled, observerblinded trial. JACC 2008;51:103. [10] Beck da Silva L, Rohde LE, Clausell N. Etiology and management of anemia in patients with heart failure: how much iron is missing? Congest Heart Fail Jan-Feb 2008;14(1):25–30. [11] Chandler G, Harchowal J, Macdougall IC. Intravenous iron sucrose: establishing a safe dose. Am J Kidney Dis 2001;38(5):988–91. [12] Chertow GM, Mason PD, Vaage-Nilsen O, Ahlmen J. Update on adverse drug events associated with parenteral iron. Nephrol Dial Transplant 2006;21(2):378–82.

Effectiveness of Intravenous Iron Sucrose in Management of Iron-Deficient Anemia of Pregnancy at Rural Hospital Set Up

Critical evaluation of iron sucrose (Malhotra, FOGSI Focus 9-11, 2009) in terms of efficacy, safety, and feasibility at rural setup for the treatment of anemia of pregnancy (Raja et al., Rawal Med J 28: 40-3, 2003) along with any reduction in blood transfusion rate at peripartum period of 37weeks to 48h within delivery. In a prospective cohort study conducted in Department of Obstetrics and Gynaecology, during the year 2008 AVBRH-Wardha, 256 consecutive women of iron-deficient anemia (IDA) treated with intravenous iron sucrose were studied for feasibility, safety, and efficacy of drug. Blood transfusion rates were compared for the years 2007 and 2008 in cases of antenatal women from 37weeks onward up to 48 h post delivery. Results were analyzed by Z-test. Mean rises in Hbg% were 1.1±0.2, 2.3±0.8, and 3.0±0.4 after 1, 2, and 3weeks, respectively. Decline in rate of blood transfusion among total anemic women at peripartum period was 9.36%. Iron sucrose therapy is very much relevant in rural scenario.

Effect of Intravenous Iron Sucrose on Exercise Tolerance in Anemic and Nonanemic Patients With Symptomatic Chronic Heart Failure and Iron Deficiency–FERRIC‐HF: A Randomized, Controlled, Observer‐Blinded Trial

Abstract. Objective. The authors tested the hypothesis that intravenous iron improves exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure (CHF) and iron deficiency.Background. Anemia is common in heart failure. Iron metabolism is disturbed, and administration of iron might improve both symptoms and exercise tolerance.Methods. The authors randomized 35 patients with CHF (age 64±13 years, peak oxygen consumption [pVO2], 14.0±2.7 mL/kg/min) to 16 weeks of intravenous iron (200 mg weekly until ferritin &gt;500 ng/mL, 200 mg monthly thereafter) or no treatment in a 2:1 ratio. Ferritin was required to be &lt;100 ng/mL or 100 to 300 ng/mL with transferrin saturation &lt;20%. Patients were stratified according to hemoglobin levels (&lt;12.5 g/dL [anemic group] vs 12.5–14.5 g/dL [nonanemic group]). The observer‐blinded primary end point was the change in absolute pVO2.Results. The difference (95% confidence interval [CI]) in the mean changes from baseline to end of study between the iron and control groups was 273 (151–396) ng/mL for ferritin (P&lt;.0001), 0.1 (−0.8 to 0.9) g/dL for hemoglobin (P=.9), 96 (−12 to 205) mL/min for absolute pVO2 (P=.08), 2.2 (0.5–4.0) mL/kg/min for pVO2/kg (P=.01), 60 (−6 to 126) sec for treadmill exercise duration (P=.08), −0.6 (−0.9 to −0.2) for New York Heart Association (NYHA) functional class (P=.007), and 1.7 (0.7–2.6) for patient global assessment (P=.002). In anemic patients (n=18), the difference (95% CI) was 204 (31–378) mL/min for absolute pVO2 (P=.02), and 3.9 (1.1–6.8) mL/kg/min for pVO2/kg (P=.01). In nonanemic patients, NYHA functional class improved (P=.06). Adverse events were similar.Conclusions. Intravenous iron loading improved exercise capacity and symptoms in patients with CHF and evidence of abnormal iron metabolism. Benefits were more evident in anemic patients.—Okonko DO, Grzeslo A, Witkowski T, et al. Effect of intravenous iron sucrose on exercise intolerance in anemic and nonanemic patients with symptomatic chronic heart failure and iron deficiency FERRIC‐HF: a randomized, controlled, observer‐blinded trial. J Am Coll Cardiol. 2008;51:103–112.

A randomized, double‐blind, placebo controlled, multi‐center study of intravenous iron sucrose and placebo in the treatment of restless legs syndrome

Iron deficiency may exacerbate symptoms in the Restless Legs Syndrome (RLS). We investigated the effect of intravenous iron sucrose or placebo on symptoms in patients with RLS and mild to moderate iron deficit. Sixty patients with primary RLS (seven males, age 46 (9) years, S-ferritin < or =45 microg/L) recruited from a cohort of 231 patients were randomly assigned in a 12-months double-blind, multi-centre study of iron sucrose 1000 mg (n = 29) or saline (n = 31). The primary efficacy variable was the RLS severity scale (IRLS) score at week 11. Median IRLS score decreased from 24 to 7 (week 11) after iron sucrose and from 26 to 17 after placebo (P = 0.123, N.S. for between treatment comparison). The corresponding scores at week 7 were 12 and 20 in the two groups (P = 0.017). Drop out rate because of lack of efficacy at 12 months was 19/31 after placebo and 5/29 patients after iron sucrose (Kaplan-Meier estimate, log rank test P = 0.0006) suggesting an iron induced superior long term RLS symptom control. Iron sucrose was well tolerated. This study showed a lack of superiority of iron sucrose at 11 weeks but found evidence that iron sucrose reduced RLS symptoms both in the acute phase (7 weeks) and during long-term follow up in patients with variable degree of iron deficiency. Further studies on target patient groups, dosing and dosing intervals are warranted before iron sucrose could be considered for treatment of iron deficient patients with RLS.

Effect of Intravenous Iron Sucrose on Exercise Tolerance in Anemic and Nonanemic Patients With Symptomatic Chronic Heart Failure and Iron Deficiency: FERRIC-HF: A Randomized, Controlled, Observer-Blinded Trial

We tested the hypothesis that intravenous iron improves exercise tolerance in anemic and nonanemic patients with symptomatic chronic heart failure (CHF) and iron deficiency. Anemia is common in heart failure. Iron metabolism is disturbed, and administration of iron might improve both symptoms and exercise tolerance. We randomized 35 patients with CHF (age 64 +/- 13 years, peak oxygen consumption [pVO2] 14.0 +/- 2.7 ml/kg/min) to 16 weeks of intravenous iron (200 mg weekly until ferritin >500 ng/ml, 200 mg monthly thereafter) or no treatment in a 2:1 ratio. Ferritin was required to be <100 ng/ml or ferritin 100 to 300 ng/ml with transferrin saturation <20%. Patients were stratified according to hemoglobin levels (<12.5 g/dl [anemic group] vs. 12.5 to 14.5 g/dl [nonanemic group]). The observer-blinded primary end point was the change in absolute pVO2. The difference (95% confidence interval [CI]) in the mean changes from baseline to end of study between the iron and control groups was 273 (151 to 396) ng/ml for ferritin (p < 0.0001), 0.1 (-0.8 to 0.9) g/dl for hemoglobin (p = 0.9), 96 (-12 to 205) ml/min for absolute pVO2 (p = 0.08), 2.2 (0.5 to 4.0) ml/kg/min for pVO2/kg (p = 0.01), 60 (-6 to 126) s for treadmill exercise duration (p = 0.08), -0.6 (-0.9 to -0.2) for New York Heart Association (NYHA) functional class (p = 0.007), and 1.7 (0.7 to 2.6) for patient global assessment (p = 0.002). In anemic patients (n = 18), the difference (95% CI) was 204 (31 to 378) ml/min for absolute pVO2 (p = 0.02), and 3.9 (1.1 to 6.8) ml/kg/min for pVO2/kg (p = 0.01). In nonanemic patients, NYHA functional class improved (p = 0.06). Adverse events were similar. Intravenous iron loading improved exercise capacity and symptoms in patients with CHF and evidence of abnormal iron metabolism. Benefits were more evident in anemic patients. (Effect of Intravenous Ferrous Sucrose on Exercise Capacity in Chronic Heart Failure; http://www.clinicaltrials.gov/ct/show/NCT00125996; NCT00125996).

Effectiveness of intravenous iron sucrose (Venofer) in the treatment of postoperative anaemia after cardiac operations

Grigolia, G.; Gogia, O.; Gvelesiani, L.; Chokhonelidze, I.; Sulaqvelidze, K.; Tutberidze, K.; Khazaradze, D.; Mikeltadze, D. Author Information

Effect of Intravenous Iron Sucrose on Oxidative Stress in Peritoneal Dialysis Patients

Aim. Intravenous iron therapy is an accepted treatment for patients receiving hemodialysis and continuous ambulatory peritoneal dialysis (CAPD). Studies have found enhanced oxidative stress in hemodialysis patients receiving intravenous iron, but there are no clinical data for CAPD patients. The aim of the current study was to investigate the effect of 100 mg of intravenous iron-sucrose on the erythrocyte (RBC) antioxidant enzymes (namely, superoxide dismutase [SOD], catalase [CAT], and glutathione peroxidase [GSHPx]) and plasma malondialdehyde (MDA), an oxidant molecule, in CAPD patients. Methods. Twelve CAPD patients receiving maintenance intravenous iron-sucrose were recruited. After a 12-hour fast, blood samples were taken for hemoglobin, iron, ferritin, and high-sensitivity C-reactive protein (hsCRP), and for baseline activities of erythrocyte antioxidant enzymes (i.e., SOD, CAT, GSHPx) and the plasma oxidant molecule, MDA. 100 mg iron-sucrose was infused over 30 minutes. Blood samples taken during (i.e., 15 minutes after commencement of infusion) and after (i.e., at 30 minutes, 60 minutes, and 6 hours after commencement) the infusion were taken for measurement of plasma iron, ferritin, TSAT, RBC SOD, CAT, GSHPx, and plasma MDA. Results. Plasma iron and transferrin saturation elevated significantly during infusion (p < 0.05). There was no significant change in erythrocyte SOD, CAT, GSHPx, or in MDA activities. There was a reduction of GSHPx activity at the 30th minute (from 153.69 ± 66.69 to 123.68 ± 25.50 mU/mL), but it was not statistically significant. The patients were grouped according to baseline ferritin (100–400 and 400–800 ng/mL); 60th-minute MDA was significantly higher in the latter group (p < 0.05). There was no correlation between hsCRP and oxidant-antioxidant balance. No correlation was noted between RBC antioxidant enzymes or plasma oxidant molecule and ferritin levels. Conclusion. There are no acute deteriorating effects from a 100 mg of intravenous iron-sucrose in CAPD patients with optimal iron stores. This dose may be applied safely in CAPD patients.

Effect of Intravenous Iron Sucrose in Peritoneal Dialysis Patients Who Receive Erythropoiesis-Stimulating Agents for Anemia

Although iron therapy is essential to optimize use of erythropoiesis-stimulating agents (ESA), randomized, controlled trials have heretofore been unavailable to evaluate reliably the efficacy of intravenous iron as an adjuvant to ESA treatment in peritoneal dialysis (PD) patients. In a multicenter trial, patients who had anemia, PD-dependent chronic kidney disease, stable ESA therapy, and a broad range of iron status (ferritin < or = 500 ng/ml, transferrin saturation < or = 25%) were randomly assigned to receive either 1 g of iron sucrose intravenously in three divided doses (300 mg over 1.5 h on days 1 and 15, 400 mg over 2.5 h on day 29) or no supplemental iron. No serious adverse drug events occurred after intravenous iron administration. The primary end point, peak hemoglobin increase, was higher (1.3 +/- 1.1 versus 0.7 +/- 1.1, mean +/- SD; P = 0.0028), and anemia intervention (transfusion, increase in ESA dose, or intravenous iron therapy not called for in protocol) occurred later (P = 0.0137) and less often in intravenous iron-treated patients compared with untreated control subjects (one of 66 [1.3%] versus five of 30 [16.7%]). Among patients who did not require intervention, iron-treated patients showed a calculated net ESA dose decrease compared with untreated control subjects. Baseline iron status did not predict responsiveness to intravenous iron therapy. Intravenous iron sucrose is an effective adjunct to ESA therapy in anemic patients with PD-dependent chronic kidney disease and is administered safely as 300 mg over 1.5 h or 400 mg over 2.5 h. Evidence of iron deficiency at baseline is not required to demonstrate intravenous iron efficacy.