Safety of RAPid INJECTion of Undiluted Ferric Carboxymaltose to Patients with Iron Deficiency Anaemia (RAPINJECT)
Safety of RAPid INJECTion of Undiluted Ferric Carboxymaltose to Patients with Iron Deficiency Anaemia (RAPINJECT): A phase II study
Haematology Unit, Monash Medical Centre, Southern Health
154 participants
Aug 1, 2012
Interventional
Conditions
Summary
Iron deficiency anaemia remains an important clinical problem. Although oral iron is usually an adequate treatment, intravenous iron is often indicated. However, currently available agents available for total dose intravenous iron replacement require prolonged administration with admission to day wards or hospital beds, consuming considerable staff and patient time and health care resources. Ferric carboxymaltose, a novel iron-carbohydrate, has been extensively trialed and has been approved by the TGA for administration of up to 1000mg of iron (diluted in saline) intravenously over 15 minutes. This promises to greatly accelerate the treatment of iron deficiency anaemia. However, preliminary data suggest that high doses of undiluted ferric carboxymaltose may be safely administered even more quickly, by rapid bolus injection. Such an approach could revolutionize the treatment of iron deficiency as patients could receive total dose iron replacement in the clinic, without requiring a hospital bed or pharmacy. We propose a three stage, single arm study two determine the safety of rapid infusion of ferric carboxymaltose at doses of up to 1000mg. We plan to recruit patients with iron deficiency anaemia presenting to Southern Health into this three stage study. In Stage 1, 30 patients will be administered iron carboxymaltose as per the TGA approved approach (up to 1000mg diluted in saline and administered over 15 minutes). Subsequently, in Stage 2, 12 patients will be assigned to a dose escalation study to identify any dose limiting toxicities associated with rapid infusion. Finally, in Stage 3, 100 subjects will be administered a total dose (based on calculated iron deficit up to 1000mg, maximum dose of 20mg/kg) of ferric carboxymaltose. The primary outcome of the study is the incidence of adverse events related to rapid infusion.
Eligibility
Inclusion Criteria2
- Patients with iron deficiency anaemia (defined as haemoglobin<120g/L in women, <130g/L in men; and either ferritin<100ng/mL or transferrin saturation<20%).
- Clinical assessment by referring physician that intravenous iron replacement is required.
Exclusion Criteria21
- Unwilling or unable to answer questions on adverse events.
- Unwilling to participate in evaluation.
- Patient or physician preference for IV iron product other than Ferric Carboxymaltose (this may be expected to occur in patients requiring total dose infusions exceeding 1000mg).
- Patients currently admitted to an inpatient bed who are considered by the trial or treating physician to be unlikely to be discharged within the next two weeks,
- Patients with severe anaemia requiring transfusion, defined as either requirement for transfusion based on clinician judgment or a haemoglobin concentration below 60g/L,
- Patients with anaemia due to causes other than iron deficiency,
- Patients with end stage renal failure requiring erythropoietin therapy,
- Patients with another acute or chronic medical condition that in the opinion of the investigators, makes them an unsuitable candidate for enrolment in the study
- Patients considered unwilling or unlikely to comply with the study or procedures,
- Pregnant women (pre-menopausal women will be screened by serum B-HCG),
- Patients with expected survival less than 3 months,
- Patients with known hypersensitivity to intravenous iron formulations,
- Patients with a recent (previous 4 weeks) history of atopy (asthma, urticaria or eczema),
- Patients who have recently received (within the previous 4 weeks), expected to receive (within the next 4 weeks) or currently receiving erythropoietin therapy,
- Patients with hereditary or transfusion acquired iron overload,
- Patients with elevation of serum liver transaminases more than twice normal,
- History of chronic abuse of analgesics, alcohol, tranquilizers, opioids or known drug
- Dependence on alcohol or illicit drugs,
- Treatment in the previous three months with any drug known to have a well-defined potential for toxicity to a major organ
- Patients who have received an iron infusion within the previous 4 weeks.
- Patients who have received a blood transfusion within the previous 2 weeks.
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Interventions
A three stage study will be undertaken. Patients will be recruited to each stage in order of recruitment. Thus, the first 30 patients recruited will receive Stage 1 of the trial, the following 12 will receive Stage 2, and the final 100 will receive Stage 3. An additional 12 patients will be recruited to Stage 3 to account for potential loss to follow up. Stage 1: Ferric carboxymaltose administered intravenously at a dose of up to 1000mg diluted in Normal Saline, administered over 15 minutes, as currently approved by the Therapeutic Goods Administration. Stage 2: Ferric carboxymaltose administered intravenously undiluted, in a bolus over 1 minute, at escalating doses in successive patients: 400mg (3 patients), 600mg (3 patients), 800mg (3 patients) and 1000mg (6 patients). Stage 3: Ferric carboxymaltose, administered intravenousl;y undiluted, in a bolus over 1 minute, at a dose of up to 1000mg as per patient requirements. All doses will be administered once in the study.
Locations(1)
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ACTRN12612000653864