Effect of oral liposomal iron versus intravenous iron for treatment of iron deficiency anaemia in CKD patients: a randomized trial.

Pisani A, Riccio E, Sabbatini M, Andreucci M, Del Rio A, Visciano B
Nephrol Dial Transplant 2015;30:645-652.
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Review by : M. Muñoz
NATA Review

In this randomised, open-label trial, 99 patients with non-dialysis chronic kidney disease (ND-CKD) and iron deficiency anaemia were assigned (2:1) to receive oral liposomal iron (30 mg/day, total dose 9000 mg; OS group) or a total dose of 1000 mg of IV ferric gluconate (125 mg infused weekly) (IV group) for 3 months. The patients were followed-up for the treatment period and 1 month after drug withdrawal.

Both treatments were equally effective in increasing Hb levels but the increase was more rapid in the IV group. Patients receiving IV iron also showed higher ferritin levels at the end of treatment. Compliance was over 90% in both groups. After treatment cessation, Hb concentrations remained stable in the IV group while they decreased back to baseline levels in the OS Group.

The authors conclude that oral liposomal iron is a safe and efficacious alternative to IV ferric gluconate to correct anaemia in ND-CKD patients, although its effect on repletion of iron stores and Hb stability after drug discontinuation are lower. Similar results were obtained in another RCT comparing oral heme iron polypeptide (11 mg tid) and IV iron sucrose (200 mg monthly) for six months, which showing that both treatments were efficacious in maintaining Hb in 40 ND-CKD patients with no differences in adverse events over the study period (Nagaraju et al. BMC Nephrology 2013;14:4).

Altogether, data from these two small studies suggest that an oral iron formulation which uses an absorption route different from that of standard oral iron salts may be an efficacious alternative to IV iron administration, at least for maintaining Hb levels, in ND-CKD patients, while preserving venous accesses, a very important issue in conservative CKD patients. Nevertheless, RCTs comparing this new iron formulation with newer IV iron compounds which allow for high dose administration in a single sitting (≥1000 mg) are needed.in this patient population.

– Manuel Muñoz

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