Limited prospective data are available on the long-term safety of Darbepoetin alfa ( Aranesp ) for treating anemia in children with chronic kidney disease ( CKD ).
In this prospective, phase IV, observational registry study, children less than or equal to 16 years of age with CKD anemia and receiving Darbepoetin alfa were observed for less than or equal to 2 years.
A total of 319 patients were included in the analysis ( mean age, 9.1 years ), 158 ( 49.5% ) of whom were on dialysis at study entry.
Of 434 serious adverse effects reported in 162 children, the most common were peritonitis ( 10.0 % ), gastroenteritis ( 6.0 % ), and hypertension ( 4.1% ).
Six patients ( 1.9% ) died ( unrelated to Darbepoetin alfa ).
Four patients ( 1.3% ) experienced six serious adverse drug reactions.
The geometric mean Darbepoetin alfa dose range was 1.4-2.0 microg/kg/month.
Mean baseline Hb ( haemoglobin ) concentration was 11.1 g/dl; mean values for children receiving and not receiving dialysis at baseline ranged between 10.9 and 11.5 g/dl and 11.2-11.7 g/dl, respectively.
Overall, 48 patients ( 15.0% ) received more than or equal to 1 transfusion.
In conclusion, no new safety signals for Darbepoetin alfa were identified in children receiving Darbepoetin alfa for CKD anemia for less than or equal to 2 years.
Based on haemoglobin concentrations and transfusion requirements, Darbepoetin alfa was effective at managing anemia in these patients. ( Xagena )
Schaefer F et al, Pediatr Nephrol 2015; Epub ahead of print