A randomized controlled trial of oral heme iron polypeptide versus oral iron supplementation for the treatment of anaemia in peritoneal dialysis patients: HEMATOCRIT trial.
What this study found
Heme iron polypeptide did not improve iron repletion, haemoglobin, or darbepoetin requirements versus oral iron, and ferritin levels were lower with heme iron polypeptide. At 6 months by intention-to-treat analysis, transferrin saturation was 22% versus 20% (P = 0.65), ferritin was 124 µg/L versus 292 µg/L (P = 0.003), haemoglobin was 111 g/L versus 113 g/L (P = 0.59), and darbepoetin dose was 20 µg/week versus 20 µg/week (P = 0.66). Adverse events were broadly similar overall (23 vs 24 total adverse events), with more gastrointestinal events in the heme iron polypeptide group, and the…
- Study & population
- Multicentre randomized controlled trial in adult peritoneal dialysis patients with end-stage renal disease who were receiving darbepoetin.
- Intervention
- Heme iron polypeptide (Proferrin ES) was given orally as two capsules daily, equivalent to 240 mg elemental iron/day, for 6 months.
- Key limitation
- The trial was relatively small, with only 32 participants randomized to the heme iron polypeptide arm and fewer analyzed per protocol.
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Open PDFOriginal abstract
BACKGROUND Preliminary clinical evidence suggests that heme iron polypeptide (HIP) might represent a promising, novel oral iron supplementation strategy in chronic kidney disease. The aim of this multi-centre randomized controlled trial was to determine the ability of HIP administration to augment iron stores in darbepoetin (DPO)-treated patients compared with conventional oral iron supplementation. METHODS Adult peritoneal dialysis (PD) patients treated with DPO were randomized 1:1 to receive two capsules daily of either HIP or ferrous sulphate per os for 6 months. The primary outcome measure was transferrin saturation (TSAT). Secondary outcomes comprised serum ferritin, haemoglobin, DPO dose and responsiveness, and adverse events. RESULTS Sixty-two patients were randomized to HIP (n = 32) or ferrous sulphate (n = 30). On intention-to-treat analysis, the median (inter-quartile range) TSAT was 22% (16-29) in the HIP group compared with 20% (17-26) in controls (P = 0.65). HIP treatment was not significantly associated with TSAT at 6 months on multivariable analysis (P = 0.95). Similar results were found on per-protocol analysis and subgroup analysis in iron-deficient patients. Serum ferritin levels at 6 months were significantly lower in the HIP group (P = 0.003), while the cost of HIP was 7-fold higher than that of ferrous sulphate. No other differences in secondary outcomes were observed. CONCLUSIONS HIP showed no clear safety or efficacy benefit in PD patients compared with conventional oral iron supplements. The reduction in serum ferritin levels and high costs associated with HIP therapy suggest that this agent is unlikely to have a significant role in iron supplementation in PD patients.