A randomised controlled trial of oral HEMe iron polypeptide Against Treatment with Oral Controlled Release Iron Tablets for the correction of anaemia in peritoneal dialysis patients (HEMATOCRIT trial)

The main hypothesis of the study is that Heme Iron Polypeptide [HIP; Proferrin (registered trademark) ES] administration will more effectively augment iron stores in erythropoeitin stimulating agent-treated peritoneal dialysis (PD) patients than conventional oral iron supplementation [Ferrogradumet (Registered Trademark)]. Patients will be randomized to receive either slow-release ferrous sulphate (1 tablet twice daily; control) or HIP (1 tablet twice daily) orally for a period of 6 months. The study will follow an open-label design but outcome assessors will be blinded to study treatment. During this 6 month study period, haemoglobin levels will be measured monthly and iron studies (including transferring saturation [TSAT] measurements) will be performed bi-monthly (as per usual clinical practice). Patients will be reviewed by PD nursing staff monthly and by nephrologists bi-monthly (as per usual clinical practice). The primary outcome measure will be the difference in TSAT levels between the 2 groups at the end of the 6 month study period, adjusted for baseline values using analysis of covariance. Secondary outcome measures will include serum ferritin concentration, haemoglobin level, darbapoeitin dosage, Key’s index (darbapoetin dosage divided by haemoglobin concentration), and occurrence of adverse events (especially gastrointestinal adverse events).