Ferric carboxymaltose assessment in patients with anaemia and NDD-CKD

• Research type

  Research Study

• Full title

  An Open-label, Multicentre, Randomised, 3-arm Study to Investigate the Comparative Efficacy and Safety of Intravenous Ferric Carboxymaltose (Ferinject® High- and Low-dosage Regimens) versus Oral Iron for the Treatment of Iron Deficiency Anaemia in Subjects with Non-dialysis-dependent Chronic Kidney Disease

• IRAS ID

  31957

• Contact name

  Iain Macdougall

• Sponsor organisation

  Vifor Pharma Inc.

• Eudract number

  2009-015579-28

• Clinicaltrials.gov Identifier

  N/A

• Research summary

  Anaemia is a common and early complication in Chronic Kidney Disease (CKD) patients. One contributing factor is iron deficiency which may be exacerbated during Erythropoietin (EPO) replacement therapy. Current guidelines for treatment of anaemia in patients not on dialysis are rather limited and largely based on the understanding within the dialysis setting. Treatments usually include an Erythropoiesis stimulating agent (ESA) in combination with iron replacement, although the relative contribution of each strategy remains unclear.This study will assess the effectiveness of iron therapy to delay ESA use, comparing 2 dosing regimens in intravenous (IV) iron therapy against the standard clinically relevant dosing of oral iron preparations.To be eligible to take part in this trial amongst other factors patients must be over the age of 18.It is estimated that 1,016 patients will be enrolled and enrolment will be completed in 12-18 months. Patients will continue treatment for approximately 52 weeks.Eligible patients will be randomised (chosen by chance, like the flip of a coin) into one of three treatment groups: Group A: 1,000mg intravenous iron (ferric carboxymaltose)Group B: 200mg intravenous iron (ferric carboxymaltose)Group C: 180-200mg oral iron (ferrous sulphate)If patients are deemed suitable for the study they will need to attend a screening visit and then return to the study centre for more visits. The baseline visit will take place up to 4 weeks after the initial screening visit. Patients will then come to the study centre again at weeks 2, 4, 6, 8, 12, 16, 20, 24, 28, 32, 36, 40, 44, 48, 52. At the end of the study, the study doctor will discuss alternative treatment for the patient.

• REC name

  London - Riverside Research Ethics Committee

• REC reference

  09/H0706/87

• Date of REC Opinion

  22 Dec 2009

• REC opinion

  Further Information Favourable Opinion