Clinical Trial
Journal Article
Multicenter Study
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Low-dose subcutaneous recombinant erythropoietin in children with chronic renal failure. Australian and New Zealand Paediatric Nephrology Association.

In a multicentre trial, low-dose subcutaneous recombinant human erythropoietin (r-Hu EPO) was evaluated in 22 children aged 4 months to 16 years with anaemia of chronic renal failure over a 12-month period. A starting dosage of 50 U/kg twice weekly was given until a target haemoglobin of 9-11 g/dl was achieved. The dosage was increased by 50 U/kg per week, each 4 weeks, if the haemoglobin did not increase by 1 g/dl per month. When the target haemoglobin was achieved, the same weekly dosage was given as a single injection. After 10 weeks, the mean haemoglobin increased from 6.7 +/- 0.7 to 9.6 +/- 1.9 g/dl (P < 0.001) and the 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 twice weekly and 1 patient on 75 U/kg twice weekly. Two children with severe renal osteodystrophy failed to respond to 95 U/kg and 150 U/kg twice weekly. The maintenance weekly dose of r-Hu EPO in 9 children over 4-12 months ranged between 45 and 125 U/kg. The Wechsler intelligence score increased in 11 children from 92 +/- 16 to 97 +/- 17 over the 12-month period (P = 0.007). No adverse effects were recorded. A starting dose of r-Hu EPO of 50 U/kg subcutaneously twice weekly is recommended as effective and safe for the majority of children with anaemia of chronic renal failure.

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