A randomized, open-label trial of iron isomaltoside 1000 (Monofer®) compared with iron sucrose (Venofer®) as maintenance therapy in haemodialysis patients (original) (raw)
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BMC Nephrology
Background: Iron deficiency is frequent in haemodialysis (HD) patients with chronic kidney disease (CKD), and intravenous iron is an established therapy for these patients. This study assessed treatment routine, effectiveness, and safety of iron isomaltoside (IIM) 5% (Diafer®) in a HD cohort. Methods: This prospective observational study included 198 HD patients converted from iron sucrose (IS) and treated with IIM according to product label and clinical routine. Data for IIM were compared to historic data for IS in 3-month intervals. The primary endpoint was to show non-inferiority for IIM versus IS in haemoglobin (Hb) maintenance. Results: Most patients (> 60%) followed a fixed low-dose iron treatment protocol. Three minutes were required for preparation and administration of IIM. Erythropoiesis-stimulating agent (ESA) was used in > 80% of patients during both IIM and IS phases. The maintenance of Hb was similar with both iron drugs; the mean Hb level was 11 g/dL, and the mean change of 0.3 g/dL (95% confidence interval: 0.1, 0.5) for IIM 0-3 months compared to IS demonstrated non-inferiority. Nine adverse drug reactions were reported in 2% of patients administered IIM. All patients had uneventful recoveries. The frequency of metallic taste was higher with IS compared to IIM (34% versus 0.5%, p < 0.0001). Conclusions: IIM is effective and well tolerated by CKD patients on HD. IIM was non-inferior to IS in maintenance of Hb, and had similar ESA requirements. The fast-push injection of IIM may enable logistical benefits in clinical practice, and the low frequency of metallic taste contributes to patient convenience.
Iron supplementation in haemodialysis - practical clinical guidelines
Nephrology Dialysis Transplantation, 1998
supplementation in haemodialysis patients. No significant adverse reactions to iron therapy were observed. Background. The aim of this prospective study was to test a new protocol for iron supplementation in haemo-Key words: erythropoietin; ferritin; haemodialysis; iron; dialysis patients, as well as to assess the utility of intravenous different iron metabolism markers in common use and their 'target' values for the correction of iron deficiency. Methods. Thirty-three of 56 chronic haemodialysis patients were selected for long-term (6 months) i.v. Introduction iron therapy at 20 mg three times per week postdialysis based on the presence of at least one of the With the widespread utilization of rHuEpo in haemofollowing iron metabolism markers: percentage of dialysis, prolonged or chronic iron overload and transferrin saturation (%TSAT) <20%; percentage of haemosiderosis have almost disappeared. Eryhypochromic erythrocytes (%HypoE) >10% and thropoietin promotes the use of iron deposits in the serum ferritin (SF) <400 mg/l. Reasons for patient bone marrow, and consequently iron deficiency is a exclusion were active inflammatory or infectious disfrequent problem resulting in resistance to the full eases, haematological diseases, psychosis, probable effect of rHuEpo. It is well known that a negative iron iron overload (SF Á400 mg/l) and/or acute need of balance may occur-up to 2 g/year [1]-and it is not blood transfusion mostly due to haemorrhage and well established whether there is a compensatory change in renal replacement treatment. increase in intestinal absorption in haemodialysis Results. More than half (51.8%) of the patients of our patients when they are iron deficient [2-5]. Oral dialysis centre proved to have some degree of iron supplementation is plagued by poor patient adherence deficiency in spite of their regular oral iron due to frequent side-effects, and interference of other supplementation. At the start of the study the mean medication with the digestive absorption [6 ]. Several haemoglobin was 10.8 g/dl and increased after the 6 studies have demonstrated the utility of i.v. iron months of iron treatment to 12.8 g/dl (P<0.0001). supplementation in correcting anaemia and sparing The use of erythropoietin decreased from 118 rHuEpo [7-10]. However the multiple publications units/kg/week to 84 units/kg/week. The criterion for evaluating the criteria to detect and to treat patients iron supplementation with the best sensitivity/specifiwith iron deficiency and the several protocols adopted city relationship (100/87.9%) was ferritin <400 mg/l. to correct this situation clearly show that there is no Patients with ferritin <100 mg/l and those with ferritin consensus [11-18]. between 100 mg/l and 400 mg/l had the same increase We administered 20 mg iron i.v. post-dialysis on a in haemoglobin but other parameters of iron metabollong-term basis because it allows approximated conism were different between the two groups. tinuous availability of iron to be incorporated into Conclusions. Routine supplementation of iron in haemoglobin under the action of rHuEpo and allowed haemodialysis patients should be performed intraveneasy control to prevent the oversaturation of transferously. Target ferritin values should be considered indirin [19,20] and iron overload. vidually and the best mean haemoglobin values were We evaluated rHuEpo dose and haemoglobin during achieved at 6 months with a mean ferritin of 456 mg/l long-term i.v. iron therapy for 6 months and evaluated (variation from to 919 mg/l). The percentage of transthe best markers to monitor this therapy. Prior to this ferrin saturation, percentage of hypochromic erythrostudy, iron status was assessed on a 3-month basis by cytes and ferritin <100 mg/l, were not considered serum ferritin (SF) and the percentage of transferrin useful parameters to monitor routine iron saturation (%TSAT); iron supplementation was given orally as a routine and the i.v. route was reserved for
Iron Administration and Clinical Outcomes in Hemodialysis Patients
Journal of the American Society of Nephrology, 2002
ABSTRACT. To evaluate the impact of parenteral iron administration on the survival and rate of hospitalization of US hemodialysis patients, a nonconcurrent cohort study of 10,169 hemodialysis patients in the United States in 1994 was conducted. The main outcome measures were patient survival and rate of hospitalization. After adjusting for 23 demographic and comorbidity characteristics among 5833 patients included in multivariable analysis, bills for ≤10 vials of iron over 6 mo showed no adverse effect on survival (adjusted relative risk [RR] = 0.93; 95% confidence interval [CI], 0.84 to 1.02;P= 0.14) when compared with none, but bills for >10 vials showed a statistically significant elevated rate of death (adjusted RR = 1.11; 95% CI, 1.00 to 1.24;P= 0.05). Bills for ≤10 vials of iron over 6 mo also showed no significant association with hospitalization (adjusted RR = 0.92; 95% CI, 0.83 to 1.03;P= 0.15), but bills for >10 vials showed statistically significant elevated risk (a...
Clinical Kidney Journal, 2016
Background: Intravenous low molecular weight iron dextran and iron sucrose have been used for correction of iron deficiency for many years and have been shown to improve anaemia in chronic kidney disease (CKD). However, there is a paucity of head to head comparisons of these parenteral iron preparations. Such comparative efficacy data would be of particular interest in resource-limited African countries, where the majority of CKD patients are unable to afford erythropoiesis-stimulating agents. Therefore, the aim of this study was to compare the effects of these two intravenous iron preparations in pre-dialysis CKD patients. Methods: Sixty-seven anaemic pre-dialysis CKD patients were randomized to one of two treatment groups. The low molecular weight iron dextran group (n = 33) received 1000 mg of low molecular weight iron dextran intravenously in four divided doses of 250 mg. The iron sucrose group (n = 34) received 1000 mg of iron sucrose intravenously in five divided doses of 200 mg. Complete blood count, serum creatinine, serum iron, unsaturated iron binding capacity, serum ferritin and transferrin saturation were assessed at baseline. The baseline parameters were repeated in all patients on Day 24. The primary outcome was the proportion of patients achieving a rise in haemoglobin (Hb) concentration of ≥1.0 g/dL after iron therapy. Results: There was no significant difference in the proportion of patients achieving the primary end point between both arms of the study: [7 (21.9%) low molecular weight iron dextran versus 11 (32.4%) iron sucrose; relative risk 0.68, 95% confidence interval (CI): 0.19-1.70; P = 0.23]. At Day 24, the mean increase in Hb concentration from baseline was comparable between the two groups: low molecular weight iron dextran 0.4 ± 0.7 g/dL versus iron sucrose 0.6 ± 0.9 g/dL, mean difference 0.2 g/dL (95% CI: −0.26-0.61; P = 0.28). The proportion of patients that experienced at least one or more adverse events was 27.3% in the iron dextran group versus 14.7% in the iron sucrose arm (P = 0.21). Conclusion: Both intravenous low molecular weight iron dextran and intravenous iron sucrose are effective in correcting iron deficiency and anaemia in pre-dialysis CKD patients.
Kidney international, 2016
Before the introduction of erythropoiesis-stimulating agents (ESAs) in 1989, repeated transfusions given to patients with end-stage renal disease caused iron overload, and the need for supplemental iron was rare. However, with the widespread introduction of ESAs, it was recognized that supplemental iron was necessary to optimize hemoglobin response and allow reduction of the ESA dose for economic reasons and recent concerns about ESA safety. Iron supplementation was also found to be more efficacious via intravenous compared to oral administration, and the use of intravenous iron has escalated in recent years. The safety of various iron compounds has been of theoretical concern due to their potential to induce iron overload, oxidative stress, hypersensitivity reactions, and a permissive environment for infectious processes. Therefore, an expert group was convened to assess the benefits and risks of parenteral iron, and to provide strategies for its optimal use while mitigating the ri...