Conventional treatment with epoetin to manage anaemia in chronic kidney disease needs
frequent administrations, changes of dose, and close monitoring of haemoglobin concentrations.
We aimed to compare the effectiveness of methoxy polyethylene glycol-epoetin beta,
given intravenously at 2-week or 4-week intervals, with epoetin treatment one to three
times per week for haemoglobin control in haemodialysis patients.
We screened 1115 adult patients from 96 centres who had stable chronic renal anaemia
and were on dialysis treatment and intravenous maintenance epoetin. We did an open-label,
parallel-group, non-inferiority trial to compare two dosing intervals of methoxy polyethylene
glycol-epoetin beta with standard epoetin treatment. We established baseline haemoglobin
concentration and eligibility over a 4-week run-in period. 223 patients were randomly
assigned to receive methoxy polyethylene glycol-epoetin beta every 2 weeks, and 224
to receive it every 4 weeks. The initial dose was based on the average epoetin dose
given during the week before the switch. The primary endpoint was change in haemoglobin
concentration between baseline and the assessment period. We analysed patients both
by intention to treat and per protocol. This study is registered with ClinicalTrials.gov,
number NCT00077610.
We excluded 133 of the 673 randomised patients from the per-protocol analysis because
they had inadequate iron status or fewer than five haemoglobin measurements during
the assessment period or needed red blood cell transfusions. The mean change from
baseline haemoglobin for patients who had switched to intravenous methoxy polyethylene
glycol-epoetin beta every 2 weeks (-0.71 g/L, 95% CI -2.20 to 0.77) or every 4 weeks
(-0.25 g/L, -1.79 to 1.29) was non-inferior to the mean change for patients who continued
treatment with epoetin (-0.75 g/L, -2.26 to 0.75) (p<0.0001 for both comparisons).
Of the 666 patients who received at least one dose of study drug, the incidence of
adverse events or serious adverse events did not differ between groups (p=0.30 and
p=0.40, respectively).
This long-acting erythropoiesis-stimulating agent is as safe as conventional epoetin
treatment, and can maintain anaemia management in haemodialysis patients when given
intravenously at 4-week dosing intervals.