Intravenous Iron Isomaltoside Research Articles

Frequency of Adverse Reaction in Antenatal Booked Patients of a Tertiary Care Centre Receiving Intravenous Iron Isomaltoside

Aim: To determine the frequency of adverse reaction in antenatal patients of Civil Hospital Karachi receiving intravenous iron isomaltoside for the treatment of iron deficiency anaemia. Methodology: A six months cross sectional study was undertaken at the department of Obstetrics & Gynaecology Civil Hospital Karachi. In this study women who weighted < 75 kg at the time of presentation to the antenatal clinic received 1000 mg parenteral iron isomaltoside infusion. Women with body weight ≥ 75 kg on the same occasion received 1500 mg parenteral iron during a minimum infusion of 30 min, diluted in 100–500 ml of saline. The patients who received parenteral iron were kept under observation in a secluded quiet room and directed to lie on her back on a comfortable bed. The researcher monitored the patient during and thirty minutes after the end of infusion to assess the adverse reactions. Results: The mean age of the women was 27.2 + 4 years, mean gestational age was 36 + 4 weeks. Out of 276 women, 17 (6%) experienced the adverse reactions. Majority (>94%) developed mild reaction which did not require any treatment. The adverse effects were significantly associated with younger age <30 years (p value .03), gestational age < 36 weeks (p value .001), use of tobacco (p value .001), hypertension (p value .001) and diabetes (p value .001) Conclusion: Findings of the study concludes that the use of a single high-dose infusion (up to 1500 mg) of paranteral iron (isomaltoside) during pregnancy is effective and safe for treating IDA in this population. Keywords: Adverse reaction, antenatal booked patients, Intravenous iron isomaltoside.

Intravenous Iron Isomaltoside for Patients With Iron Deficiency Undergoing Elective Surgery


 The results of 1 randomized controlled trial did not find a difference in functional status (6-minute walk distance and New York Heart Association class), hand grip strength, or health-related quality of life for patients who underwent a transcatheter aortic valve implantation treated with iron isomaltoside versus placebo.
 There was 1 (1.4%) hypersensitivity reaction and 1 (1.4%) episode of chest pain in patients treated with iron isomaltoside in the randomized controlled trial. Rates of other adverse events were similar between patients treated with iron isomaltoside and placebo.

Perioperative changes in haemoglobin and ferritin concentrations from preoperative intravenous iron isomaltoside for iron deficiency anaemia in patients with colorectal cancer: A pilot randomised controlled trial.

BackgroundPatients with colorectal cancer have a high risk of iron deficiency anaemia (IDA) due to chronic tumour induced blood loss, a reduced dietary iron intake from poor nutrition or gastrointestinal malabsorption. This pilot, double blinded, randomised controlled trial (RCT) examined the effect and feasibility of using preoperative iron isomaltoside for treating iron deficiency anaemia.MethodsForty eligible adults with IDA were randomised to receive either intravenous iron isomaltoside (20 mg.kg-1 up to 1000 mg over 30 minutes) or usual preoperative care (control) three weeks before scheduled colorectal surgery. The primary outcomes were perioperative changes in haemoglobin and ferritin concentrations.ResultsThe recruitment rate was 78% of all eligible referred patients (1.9 patients/month). The haemoglobin and ferritin concentrations were higher in the iron isomaltoside group than the control group over the perioperative period (group*time interaction P = 0.042 and P < 0.001 respectively). Mean haemoglobin change from baseline to before surgery was higher in the iron isomaltoside group (7.8, 95% CI: 3.2 to 12.3 g.l-1) than the control group (1.7, 95% CI: -1.9 to 5.3 g.l-1) [mean difference 6.1, 95% CI: 0.3 to 11.8 g.l-1; P = 0.040]. The ferritin change from baseline to before surgery between groups was large in favour of the iron isomaltoside group (mean difference 296.9, 95% CI: 200.6 to 393.2 μg.l-1; P < 0.001]. There were no differences between groups in packed red blood cell transfusions needed, surgical complications, quality of recovery and days (alive and) at home within 30 days after surgery.ConclusionIron isomaltoside therapy was safe and had a minimal effect on perioperative changes in haemoglobin concentration. Given the slow recruitment and new evidence emerging during the conduct of this study, conducting a multi-centre RCT based on the current pilot trial protocol is unlikely to be feasible.Trial registrationClinicalTrials.gov NCT03565354.

Efficacy and safety of intravenous iron isomaltoside in postpartum anaemia

Efficacy and safety of intravenous iron isomaltoside in postpartum anaemia

Interventions for treating iron deficiency anaemia in inflammatory bowel disease.

Interventions for treating iron deficiency anaemia in inflammatory bowel disease.

Hypophosphataemia after treatment of iron deficiency with intravenous ferric carboxymaltose or iron isomaltoside-a systematic review and meta-analysis.

AimsHypophosphataemia is an increasingly recognized side‐effect of ferric carboxymaltose (FCM) and possibly iron isomaltoside/ferric derisomaltose (IIM), which are used to treat iron deficiency. The aim of this study was to determine frequency, severity, duration and risk factors of incident hypophosphataemia after treatment with FCM and IIM.MethodsA systematic literature search for articles indexed in EMBASE, PubMed and Web of Science in years 2005–2020 was carried out using the search terms ‘ferric carboxymaltose’ OR ‘iron isomaltoside’. Prospective clinical trials reporting outcomes on hypophosphataemia rate, mean nadir serum phosphate and/or change in mean serum phosphate from baseline were selected. Hypophosphataemia rate and severity were compared for studies on IIM vs. FCM after stratification for chronic kidney disease. Meta‐regression analysis was used to investigate risk factors for hypophosphataemia.ResultsAcross the 42 clinical trials included in the meta‐analysis, FCM induced a significantly higher incidence of hypophosphataemia than IIM (47%, 95% CI 36–58% vs. 4%, 95% CI 2–5%), and significantly greater mean decreases in serum phosphate (0.40 vs. 0.06 mmol/L). Hypophosphataemia persisted at the end of the study periods (maximum 3 months) in up to 45% of patients treated with FCM. Meta‐regression analysis identified low baseline serum ferritin and transferrin saturation, and normal kidney function as significant predictors of hypophosphataemia.ConclusionFCM is associated with a high risk of hypophosphataemia, which does not resolve for at least 3 months in a large proportion of affected patients. More severe iron deficiency and normal kidney function are risk factors for hypophosphataemia.

NIMO-CKD-UK: a real-world, observational study of iron isomaltoside in patients with iron deficiency anaemia and chronic kidney disease

BackgroundIntravenous iron is often used to treat iron deficiency anaemia in non-dialysis chronic kidney disease (ND-CKD), but the optimal dosing regimen remains unclear. We evaluated the impact of high- versus low-dose intravenous iron isomaltoside on the probability of retreatment with intravenous iron in iron-deficient ND-CKD patients.MethodsThis real-world, prospective, observational study collected data from 256 ND-CKD patients treated for anaemia in the UK. Following an initial course of iron isomaltoside, patients were followed for ≥12 months. Iron dose and the need for retreatment were determined at the investigators’ discretion. The primary study outcome was the need for retreatment at 52 weeks compared between patients who received >1000 mg of iron during Course 1 and those who received ≤1000 mg. Safety was evaluated through adverse drug reactions.ResultsThe probability of retreatment at Week 52 was significantly lower in the >1000 mg iron group (n = 58) versus the ≤1000 mg group (n = 198); hazard ratio (95% confidence interval [CI]): 0.46 (0.20, 0.91); p = 0.012. Mean (95% CI) haemoglobin increased by 6.58 (4.94, 8.21) g/L in the ≤1000 mg group and by 10.59 (7.52, 13.66) g/L in the >1000 mg group (p = 0.024). Changes in other blood and iron parameters were not significantly different between the two groups. Administering >1000 mg of iron isomaltoside saved 8.6 appointments per 100 patients compared to ≤1000 mg. No serious adverse drug reactions were reported. Of the patients who received ≤1000 mg of iron in this study, 82.3% were eligible for a dose >1000 mg.ConclusionsThe >1000 mg iron isomaltoside regimen reduced the probability of retreatment, achieved a greater haemoglobin response irrespective of erythropoiesis-stimulating agent treatment, and reduced the total number of appointments required, compared to the ≤1000 mg regimen. Many of the patients who received ≤1000 mg of iron were eligible for >1000 mg, indicating that there was considerable underdosing in this study.Trial registrationClinicalTrials.gov NCT02546154, 10 September 2015.

Intravenous iron isomaltoside versus oral iron supplementation for treatment of iron deficiency in pregnancy: protocol for a randomised, comparative, open-label trial

BackgroundIron deficiency is common in pregnancy. If left untreated, iron deficiency can lead to iron deficiency anaemia, which is a condition related to maternal and neonatal morbidity. The prevalence of iron deficiency increases through the trimesters, which means that women with iron deficiency in the beginning of pregnancy also have a great risk of developing iron deficiency anaemia during pregnancy. Standard treatment is oral iron in individualised intensified doses based on screening values in 1st trimester.Maternal symptoms of iron deficiency and iron deficiency anaemia include fatigue, reduced physical performance, and restless legs syndrome (RLS). Severe anaemia may cause dizziness, dyspnea, palpitation, orthostatism, and syncope, and it decreases the woman’s ability to cope with blood loss during delivery. The anaemia may also compromise contractility in the uterine musculature increasing the risk for prolonged labour, caesarean section, and postpartum haemorrhage. Foetal iron deficiency may cause low birthweight and adversely affect foetal and early childhood brain development with long-term deficits.MethodsIn this randomised comparative, open-label, single-centre, phase IV trial, 200 pregnant women between 14 and 21 weeks of gestation who have iron deficiency after 4 weeks of standard treatment will be randomised 1:1 to either a single 1000 mg dose of intravenously administered ferric derisomaltose/iron isomaltoside 1000 or a fixed dose of 100 mg oral ferrous fumarate containing 60 mg ascorbic acid.The primary endpoint is to prevent iron deficiency anaemia defined by a low level of haemoglobin throughout the trial. Other endpoints include other haematological indices of iron deficiency and anaemia, clinical outcomes by questionnaires, and collection of adverse events. Explorative endpoints by medical record follow-up include complications up to 7 days after delivery.DiscussionThis trial will provide evidence on how to prevent iron deficiency anaemia. The trial population represents a clinical reality where pregnant women often have sustained iron deficiency despite an increased oral iron dose. Thus, this evidence can be used to consider the optimal 2nd line of treatment in iron-deficient pregnant women.Trial registrationEuropean Union Drug Regulating Authorities Clinical Trials Database 2017-000776-29. Registered on 3 May 2017.ClinicalTrials.gov NCT03188445. Registered on 15 June 2017.

Effects of Iron Isomaltoside vs Ferric Carboxymaltose on Hypophosphatemia in Iron-Deficiency Anemia

Intravenous iron enables rapid correction of iron-deficiency anemia, but certain formulations induce fibroblast growth factor 23-mediated hypophosphatemia. To compare risks of hypophosphatemia and effects on biomarkers of mineral and bone homeostasis of intravenous iron isomaltoside (now known as ferric derisomaltose) vs ferric carboxymaltose. Between October 2017 and June 2018, 245 patients aged 18 years and older with iron-deficiency anemia (hemoglobin level ≤11 g/dL; serum ferritin level ≤100 ng/mL) and intolerance or unresponsiveness to 1 month or more of oral iron were recruited from 30 outpatient clinic sites in the United States into 2 identically designed, open-label, randomized clinical trials. Patients with reduced kidney function were excluded. Serum phosphate and 12 additional biomarkers of mineral and bone homeostasis were measured on days 0, 1, 7, 8, 14, 21, and 35. The date of final follow-up was June 19, 2018, for trial A and May 29, 2018, for trial B. Intravenous administration of iron isomaltoside, 1000 mg, on day 0 or ferric carboxymaltose, 750 mg, infused on days 0 and 7. The primary end point was the incidence of hypophosphatemia (serum phosphate level <2.0 mg/dL) between baseline and day 35. In trial A, 123 patients were randomized (mean [SD] age, 45.1 [11.0] years; 95.9% women), including 62 to iron isomaltoside and 61 to ferric carboxymaltose; 95.1% completed the trial. In trial B, 122 patients were randomized (mean [SD] age, 42.6 [12.2] years; 94.1% women), including 61 to iron isomaltoside and 61 to ferric carboxymaltose; 93.4% completed the trial. The incidence of hypophosphatemia was significantly lower following iron isomaltoside vs ferric carboxymaltose (trial A: 7.9% vs 75.0% [adjusted rate difference, -67.0% {95% CI, -77.4% to -51.5%}], P < .001; trial B: 8.1% vs 73.7% [adjusted rate difference, -65.8% {95% CI, -76.6% to -49.8%}], P < .001). Beyond hypophosphatemia and increased parathyroid hormone, the most common adverse drug reactions (No./total No.) were nausea (iron isomaltoside: 1/125; ferric carboxymaltose: 8/117) and headache (iron isomaltoside: 4/125; ferric carboxymaltose: 5/117). In 2 randomized trials of patients with iron-deficiency anemia who were intolerant of or unresponsive to oral iron, iron isomaltoside (now called ferric derisomaltose), compared with ferric carboxymaltose, resulted in lower incidence of hypophosphatemia over 35 days. However, further research is needed to determine the clinical importance of this difference. ClinicalTrials.gov Identifiers: NCT03238911 and NCT03237065.

Efficacy of Intraoperative Administration of Iron Isomaltoside for Preventing Postoperative Anaemia after Total Knee Arthroplasty: A Randomised Controlled Trial

Background: Postoperative anaemia is common after total knee arthroplasty (TKA). Emerging evidence shows the beneficial effects of perioperative iron supplementation in patients at risk of postoperative anaemia. In this study, we aimed to evaluate the efficacy of intraoperative administration of iron isomaltoside for preventing post-TKA anaemia. Methods: This prospective randomised, controlled, double-blinded, parallel-group study was conducted at a tertiary care teaching hospital in Seoul, Korea. Patients undergoing unilateral TKA were randomly assigned to receive intravenous iron isomaltoside or placebo intraoperatively, based on a computer-generated randomisation list. The administered dose of iron isomaltoside was determined based on preoperative haemoglobin level and body weight of each patient according to the manufacturer’s recommendation. The primary outcome measure was the incidence of postoperative anaemia at 30 days after TKA, analysed by intention-to-treat. Findings: Between March 29, 2018, and April 16, 2019, 164 patients were screened for eligibility. In total, 89 patients were included in the final analysis (44 in the treatment group; 45 in the control group). The incidence of postoperative anaemia at 30 days after TKA was significantly lower in the treatment group than that in the control group (15/44 [34·1%]) vs 28/45 [62·2%]; relative risk, 0·55 [95% CI 0·34–0·88], P=0·008). Haemoglobin level, serum ferritin concentrations, and iron saturation were also significantly higher in the treatment group at 30 days after TKA. However, there were no significant differences in both quality of life assessments. Interpretation: Intraoperative administration of iron isomaltoside effectively prevents post-TKA anaemia, and thus it can be included in patient blood management protocols for reducing postoperative anaemia in patients undergoing TKA. Trial Registration: This study is registered with ClinicalTrials.gov (number NCT03470649) and has completed recruitment. Funding Statement: This study was funded by Phambio Korea Inc., Seoul, Korea. Declaration of Interests: The authors declare that they have no conflicts of interest. Ethics Approval Statement: This prospective randomised, controlled, double-blinded, parallel-group study was approved by the Institutional Review Board of Soul National University Hospital, Seoul, Korea (No. H-1709-079-885). The study was conducted in accordance with the Declaration of Helsinki, and written informed consent was obtained from all participants.

Feasibility of Intravenous Iron Isomaltoside to Improve Anemia and Quality of Life During Palliative Chemotherapy for Esophagogastric Adenocarcinoma

Background: Anemia is common with esophagogastric adenocarcinoma, increasing mortality, blood transfusions, and reducing quality of life (QOL). No clear evidence exists for safe and effective treatment.Methods: Anemic patients (Hb <12 g/dl women, <13 g/dl men) with esophagogastric adenocarcinoma were recruited before initiation of palliative chemotherapy. Patients were randomized to standard care or single dose of intravenous iron isomaltoside (IVI) before chemotherapy. Post-chemotherapy changes in hemoglobin (Hb), ferritin, transferrin saturations (TSAT), blood transfusions, and QOL were recorded for three cycles of chemotherapy.Results: Twenty-seven patients were randomized to standard care (n = 13) or IVI (n = 14). No significant change in Hb was seen (standard care MD –0.6 g/dl 95% CI –0.1–1.1 g/dl, P = 0.336; IVI MD +0.5 g/dl 95% CI –0.1–1.1 g/dl, P = 0.903). An increase in ferritin was seen with IVI after cycle one of chemotherapy (standard care 116 ng/ml; IVI 770 ng/ml, P < 0.05). No difference in blood transfusions was seen between groups (P = 0.851). IVI improved QOL with physical well-being, emotional well-being, anemia-specific QOL, trial outcome index, and total scores all exceeding minimum clinically important difference. No improvement was seen with standard care.Conclusions: This feasibility study suggests IVI improves quality of life and ferritin. Larger adequately powered studies are required to definitively conclude if hemoglobin and blood transfusion changes with IVI.

Safety and efficacy of intravenous iron isomaltoside for correction of anaemia in patients with inflammatory bowel disease in everyday clinical practice

Aims: Iron deficiency anaemia (IDA) is common in patients with inflammatory bowel disease (IBD), who are often treated with intravenous iron. This observational study aimed to investigate the effectiveness and safety of iron isomaltoside in routine practical care of IDA in IBD patients.Methods: The study included 197 IBD patients designated for treatment with iron isomaltoside. Treatment was administered according to routine practice. Data were recorded at baseline and after approximately 4, 8, and 16 weeks. Efficacy data included haemoglobin (Hb) levels and haematinics, while safety data included adverse drug reactions and safety laboratory variables.Results: Patients received a mean (range) cumulative dose of 1304 (100–3500) mg iron isomaltoside. Hb increased from 10.7(±1.6) g/dL at baseline to 13.1(±1.5) g/dL at the final visit. In addition, serum iron, ferritin and transferrin saturation increased and soluble transferrin receptor decreased. Calprotectin decreased, as did IBD symptom scores, Harvey–Bradshaw Index (Crohn’s disease) and partial Mayo score (Ulcerative colitis). About 8% of patients reported transient adverse reactions, most commonly skin reactions, nausea and vomiting, and 2% SAEs, most frequently tachycardia.Conclusion: Iron isomaltoside was demonstrated to be effective and had a good safety profile in IBD patients in everyday clinical practice in Germany.

Sa1684 - No Signs of Symptomatic Hypophosphatemia or Intact Fibroblast Groth Factor 23 Induced Renal Phosphate Wasting with Intravenous Iron Isomaltoside in Inflammatory Bowel Disease Patients

Sa1684 - No Signs of Symptomatic Hypophosphatemia or Intact Fibroblast Groth Factor 23 Induced Renal Phosphate Wasting with Intravenous Iron Isomaltoside in Inflammatory Bowel Disease Patients

Intravenous iron isomaltoside treatment of women suffering from severe fatigue after postpartum hemorrhage

Background and objectives: To explore if intravenous iron isomaltoside (Monofer®) leads to a better relief of fatigue than current treatment practice with oral iron in women suffering from severe fatigue after postpartum hemorrhage.Materials and methods: This is a subanalysis of a single-center, open-label, randomized controlled trial conducted in women suffering from postpartum hemorrhage. Participants were randomized 1:1 to 1200 mg iron isomaltoside or current treatment practice with oral iron. We measured fatigue by the Multidimensional Fatigue Inventory (MFI) and Edinburgh Postnatal Depression Scale, and determined hematological parameters. The subanalysis includes all participants with a high fatigue score (MFI physical fatigue score >15) at inclusion. The primary endpoint was aggregated change in physical fatigue score from inclusion to 12 weeks postpartum with a predefined minimum clinically relevant difference of 1.8. The trial is registered at ClinicalTrials.gov (identifier: NCT01895218).Results: A total of 85 women had a high fatigue score at inclusion. The aggregated change in physical fatigue score was −2.3 (confidence interval 95%: −3.3; −1.3) (p < .0001) in favor of iron isomaltoside. Significant differences in other fatigue and depression scores and hematological parameters were observed and all in favor of iron isomaltoside. There were no differences in side effects between the groups.Conclusions: In women suffering from severe fatigue after postpartum hemorrhage, a single dose of iron isomaltoside is associated with a statistically significant and clinically relevant reduction in aggregated physical fatigue within 12 weeks after delivery, when compared to current treatment practice with oral iron and with a similar safety profile.

Iron concentration in breast milk normalised within one week of a single high-dose infusion of iron isomaltoside in randomised controlled trial.

We compared the iron concentration in breast milk after a single high dose of intravenous iron isomaltoside or daily oral iron for postpartum haemorrhage. In this randomised controlled trial, the women were allocated a single dose of intravenous 1200 mg iron isomaltoside or oral iron at a mean daily dose of 70.5 mg. We included 65 women with sufficient breast milk three days after inclusion - 30 from the intravenous iron group and 35 from the oral iron group - and collected breast milk and maternal blood samples three days and one week after allocation. The mean (±SD) iron concentration in breast milk in the intravenous and oral groups was 0.72 ± 0.27 and 0.40 ± 0.18 mg/L at three days (p < 0.001) and 0.47 ± 0.17 and 0.44 ± 0.25 mg/L after one week (p = 0.64). Baseline samples were not available that soon after birth. A single high dose of intravenous iron isomaltoside for postpartum haemorrhage led to a transient increase in the iron concentration in breast milk three days after treatment compared with oral iron. The difference disappeared one week after treatment, and mean iron concentrations were within the normal range in all samples.

A Randomized Noninferiority Trial of Intravenous Iron Isomaltoside versus Oral Iron Sulfate in Patients with Nonmyeloid Malignancies and Anemia Receiving Chemotherapy: The PROFOUND Trial

Study ObjectiveA safe alternative to erythropoiesis‐stimulating agents to treat anemia is warranted in patients with cancer and anemia; thus the objective of this trial was to compare the efficacy and safety of intravenous (IV) iron isomaltoside with oral iron in patients with cancer and anemia by testing the noninferiority of IV versus oral iron.DesignPhase III, prospective, open‐label, comparative, randomized, noninferiority, multicenter trial.SettingForty‐seven hospitals or private cancer clinics in Asia, the United States, and Europe.PatientsA total of 350 patients with cancer and anemia.InterventionPatients were randomized in a 2:1 ratio to either intravenous iron isomaltoside or oral iron sulfate. Patients in the iron isomaltoside group were then randomized into an infusion subgroup (single intravenous infusions of a maximum dose of 1000 mg over 15 min) or a bolus injection subgroup (bolus injections of 500 mg over 2 min).Measurements and Main ResultsThe primary efficacy outcome was change in hemoglobin concentration from baseline to week 4. Changes in other relevant hematology variables, effect on quality of life, and safety outcomes were also assessed. The primary efficacy outcome was tested for noninferiority, whereas the remaining outcomes were tested for superiority. Iron isomaltoside was noninferior to oral iron in change in hemoglobin concentration from baseline to week 4 (difference estimate 0.016, 95% confidence interval –0.26 to 0.29, p<0.001). A faster onset of the hemoglobin response was observed with infusion of iron isomaltoside (superiority test: p=0.03 at week 1), and a sustained effect on hemoglobin level was shown in both the iron isomaltoside and oral iron treatment groups until week 24. A significant mean decrease in fatigue score was observed from baseline to week 12 in the iron isomaltoside group (p<0.001) but not in the oral iron group (p=0.057). A higher proportion of patients treated with oral iron experienced adverse drug reactions (18.8% vs 6.6%, p<0.001) and discontinued the trial due to intolerance (8.0% vs 0.9%, p=0.001). Transient hypophosphatemia (phosphate level less than 2 mg/dl) was reported at similar low frequencies among the groups: 7.1% in the iron isomaltoside infusion subgroup versus 8.5% in the iron isomaltoside bolus injection subgroup versus 5.4% in the oral iron group.ConclusionThis trial demonstrated comparable sustained increases in hemoglobin concentration over time with both iron isomaltoside and oral iron. Iron isomaltoside was better tolerated than oral iron, and fatigue was significantly decreased with iron isomaltoside. Low rates of clinically insignificant hypophosphatemia were reported in patients receiving both treatments.

P444. High-dose intravenous iron isomaltoside infusion is not associated with an increase in intact fibroblast growth factor 23 (iFGF23) in patients with inflammatory bowel disease

P444. High-dose intravenous iron isomaltoside infusion is not associated with an increase in intact fibroblast growth factor 23 (iFGF23) in patients with inflammatory bowel disease

A 1-year trial of repeated high-dose intravenous iron isomaltoside 1000 to maintain stable hemoglobin levels in inflammatory bowel disease

Objective. Iron isomaltoside 1000 (Monofer®) is a high-dose intravenous (IV) iron, which in a recent 8 weeks trial in inflammatory bowel disease (IBD) subjects with iron deficiency anemia (IDA) demonstrated good tolerability and efficacy. The present trial is an extension to this trial, which evaluates the need for additional high IV iron doses to maintain a stable hemoglobin (Hb) ≥12.0 g/dl. Material and methods. This was a prospective, open-label, 12 months trial of European IBD subjects willing to participate after completing the lead-in trial. Subjects were allowed re-dosing with 500–2000 mg single doses of iron isomaltoside 1000 infused over ∼15 min at 3 months intervals depending on a predefined algorithm. Outcome measures included Hb, safety parameters and need for additional iron dosing. Results. A total of 39 subjects were enrolled of which 34 subjects required re-dosing with a median cumulative 1-year dose of 1.8 g (mean cumulative dose 2.2 g). The mean (SD) Hb was 12.3 (1.5) g/dl at baseline, 12.8 (1.6) g/dl at 3 months, 12.8 (1.6) g/dl at 6 months, 12.9 (1.4) g/dl at 9 months and 12.9 (1.6) g/dl at 12 months. Seventy-four percent of subjects who had an Hb ≥12.0 g/dl at baseline were able to maintain Hb ≥12.0 g/dl till the end of the trial at 12 months. Nonserious probably related hypersensitivity reactions without significant hypotension were reported at the beginning of the infusion in two subjects, who recovered without sequelae. Conclusion. Repeated treatment of iron deficiency with iron isomaltoside 1000 could avoid episodes of IDA without major safety issues.Trial registration: ClinicalTrial.gov identifier: NCT01410435.

P339. High dose intravenous iron isomaltoside 1000 in subjects with inflammatory bowel disease - the PROMISE trial

P339. High dose intravenous iron isomaltoside 1000 in subjects with inflammatory bowel disease - the PROMISE trial

Intravenous iron isomaltoside 1000 administered by high single-dose infusions or standard medical care for the treatment of fatigue in women after postpartum haemorrhage: study protocol for a randomised controlled trial.

BackgroundPostpartum haemorrhage can lead to iron deficiency with and without anaemia, the clinical consequences of which include physical fatigue. Although oral iron is the standard treatment, it is often associated with gastrointestinal side effects and poor compliance. To date, no published randomised controlled studies have compared the clinical efficacy and safety of standard medical care with intravenous administration of iron supplementation after postpartum haemorrhage.The primary objective of this study is to compare the efficacy of an intravenous high single-dose of iron isomaltoside 1000 with standard medical care on physical fatigue in women with postpartum haemorrhage.Methods/DesignIn a single centre, open-labelled, randomised trial, women with postpartum haemorrhage exceeding 700 mL will be allocated to either a single dose of 1,200 mg of iron isomaltoside 1000 or standard medical care. Healthy parturients with a singleton pregnancy will be included within 48 hours after delivery.Participants will complete structured questionnaires that focus on several dimensions of fatigue and mental health (Multidimensional Fatigue Inventory, Edinburgh Postnatal Depression Scale and the Postpartum Questionnaire), at inclusion and at follow-up visits after three days, one week, three weeks, eight weeks, and 12 weeks postpartum. The primary endpoint is the aggregated change in physical fatigue score within 12 weeks postpartum, as measured by a subscale of the Multidimensional Fatigue Inventory. The primary objective will be considered to have been met if an intravenous high single dose of iron isomaltoside 1000 is shown to be superior to standard medical care in women after postpartum haemorrhage regarding physical fatigue.For claiming superiority, we set the minimal clinically relevant difference between the mean scores at 1.8, and the assumed standard deviation at 4.2. Hence, 87 participants per treatment group are needed in order to demonstrate superiority; to provide an extra margin for missing data and dropouts, 200 women will be included.DiscussionThe study will provide evidence on relevant clinical outcomes beyond biochemical parameters for intravenous iron isomaltoside 1000 compared to standard medical care in women after postpartum haemorrhage.Trial registrationThis trial is registered with Clinicaltrials.gov (identifier: NCT01895218) on 26 June 2013.Electronic supplementary materialThe online version of this article (doi:10.1186/1745-6215-16-5) contains supplementary material, which is available to authorized users.