A multicenter study was carried out with thirty four patients sufferin
g from severe chronic renal failure, who had not undergone dialysis, i
n order to evaluate the response of anemia to treatment with rHuEPO. T
he study consisted of two protocols of treatment: Protocol A, in which
eighteen patients were treated with 75 U/kg/once a week; and Protocol
B, in wich sixteen patients were treated with 25 U/kg/thrice a week.
Patients in both protocols had the same characteristics, and rHuEPO wa
s subcutaneously administered. The criteria of inclusion were: hemoglo
bin <10 g/dl, serum ferritin >80 ng/ml, and three month period of trea
tment as a minimum. All patients obtained a satisfactory response to t
he treatment with rHuEPO, and they did not experience undesirable effe
cts on the blood pressure and the course of the nephropathy. The incre
ase in the hemoglobin levels, with a low maintenance dose of rHuEPO wa
s similar for both groups of patients throughout the treatment. Clinic
al progression was not different between protocol A and B groups for a
ny of the evaluated parameters, i.e. hemoglobin levels, total dose of
administered rHuEPO, ferritin levels, blood pressure and progression o
f renal failure. Patients showed an evident improvement of their clini
cal condition when their hemoglobin levels were reasonably increased.
We conclude that rHuEPO, subcutaneously administered by a single weekl
y dose as well as by three fractionated lower weekly doses, is effecti
ve for the treatment of the anemia in patients suffering chronic renal
failure, who are not receiving regular dialysis. Patients receiving t
his treatment show an evident improvement of their clinical condition.