A randomized trial of iron isomaltoside 1000 versus oral iron in non dialysis dependent chronic kidney disease patients with anaemia
Background Iron deficiency anaemia is common in patients with non dialysis dependent chronic kidney disease (NDD CKD) and is often treated with oral or intravenous (IV) iron therapy. This trial compared the efficacy and safety of IV iron isomaltoside 1000 (Monofer(r) and oral iron in NDD CKD patients with renal related anaemia. Methods The trial was a Phase III open label, comparative, multicentre, non inferiority trial conducted in 351 iron deficient NDD CKD patients, randomized 2:1 to either iron isomaltoside 1000 (Group A) or iron sulphate administered as 100 mg elemental oral iron twice daily (200 mg daily) for 8 weeks (Group B) The patients in Group A were randomized into A1 (infusion of max. 1000 mg single doses over 15 min) and A2 (bolus injections of 500 mg over 2 min) A modified Ganzoni formula was used to calculate IV iron need. The primary end point was change in haemoglobin concentrations from baseline to Week 4. Results Iron isomaltoside 1000 was both non inferior to oral iron at Week 4 (P 0.001) and sustained a superior increase in haemoglobin from Week 3 until the end of the study at Week 8 (P 0.009 at Week 3) The haemoglobin response was more pronounced with iron isomaltoside 1000 doses =1000 mg (P 0.05) Serum ferritin and transferrin saturation concentrations were also significantly increased with IV iron. Adverse drug reactions were observed in 10.5% in the iron isomaltoside 1000 group and 10.3% in the oral iron group. More patients treated with oral iron sulphate withdrew from the study due to adverse events (4.3 versus 0.9% P 0.2) Conclusions Iron isomaltoside 1000 was more efficacious than oral iron for increase in haemoglobin and proved to be well tolerated at the tested dose levels in NDD CKD patients.
Nephrology, dialysis, transplantation official publication of the European Dialysis and Transplant Association European Renal Association