Efficacy of Reticulocyte Haemoglobin Equivalent-Guided Versus Transferrin Saturation-Guided Iron Supplement Protocol in Haemodialysis Patients: A Multicenter Cluster Randomized Controlled Trial.

BACKGROUND

Iron deficiency is common in patients receiving haemodialysis and contributes to adverse outcomes. Conventional iron biomarkers, including ferritin and transferrin saturation (TSAT), have limitations and may be less accessible in some settings. Reticulocyte haemoglobin equivalent (RET-He) is a lower-cost, potentially more accessible marker for detection of iron deficiency. This study evaluated whether RET-He-guided intravenous iron supplementation is non-inferior to TSAT-guided supplementation in haemodialysis patients.

METHODS

In this randomized non-inferiority trial, 160 haemodialysis patients were randomized to a TSAT-guided group (n = 79) or RET-He-guided group (n = 81). Intravenous iron was administered in both groups according to prespecified protocols. The primary outcome was the erythropoietin resistance index (ERI) at 3 and 6 months. RET-He guidance was considered non-inferior if the upper bound of the 95% confidence interval (CI) for the between-group mean difference was ≤ 160 units/week/g/dL. Secondary outcomes included all-cause mortality, hospitalization, cardiovascular events, blood transfusion, and infection.

RESULTS

Baseline characteristics were comparable between groups. RET-He-guided supplementation was non-inferior to TSAT-guided supplementation for ERI at 3 months (mean difference, -35.92; 95% CI, -155.60 to 90.29; p = 0.001 for non-inferiority) and 6 months (mean difference, -39.68; 95% CI, -187.01 to 107.64; p = 0.004 for non-inferiority). The RET-He group received significantly lower cumulative intravenous iron doses. Secondary outcomes did not differ significantly, although the trial was not powered for these clinical outcomes.

CONCLUSION

RET-He-guided intravenous iron supplementation was non-inferior to TSAT-guided supplementation for reducing ERI over 6 months. Use of RET-He may offer a lower-cost and more accessible strategy for anaemia management in haemodialysis patients, particularly in resource-limited settings.