In a multicentre trial, low-dose subcutaneous recombinant human erythr
opoietin (r-Hu EPO) was evaluated in 22 children aged 4 months to 16 y
ears with anaemia of chronic renal failure over a 12-month period. A s
tarting dosage of 50 U/kg twice weekly was given until a target haemog
lobin of 9-11 g/dl was achieved. The dosage was increased by 50 U/kg p
er week, each 4 weeks, if the haemoglobin did not increase by 1 g/dl p
er month. When the target haemoglobin was achieved, the same weekly do
sage was given as a single injection. After 10 weeks, the mean haemogl
obin increased from 6.7 +/- 0.7 to 9.6 +/- 1.9 g/dl (P < 0.001) and th
e haematocrit from 19.8% +/- 2.4% to 29.3% +/- 6.3% (P < 0.001). By 4
months the target haemoglobin was achieved in 19 patients on 50 U/kg t
wice weekly and 1 patient on 75 U/kg twice weekly. Two children with s
evere renal osteodystrophy failed to respond to 95 U/kg and 150 U/kg t
wice weekly. The maintenance weekly dose of r-Hu EPO in 9 children ove
r 4-12 months ranged between 45 and 125 U/kg. The Wechsler intelligenc
e score increased in II children from 92 +/- 16 to 97 +/- 17 over the
12-month period (P = 0.007). No adverse effects were recorded. A start
ing dose of r-Hu EPO of 50 U/kg subcutaneously twice weekly is recomme
nded as effective and safe for the majority of children with anaemia o
f chronic renal failure.