[Treatment of anemia in hemodialyzed children using recombinant human erythropoietin (Eprex). Results of a French multicenter clinical trial].
Intravenous recombinant human erythropoietin (Eprex Cilag) was used in 28 hemodialyzed children, treated in 3 French paediatric centers, from November 1989 to November 1990. Transfusion dependency disappeared in all cases: the number of transfusions decreased from 7.3 unit/patient/year to 0.6 unit/pt/year. The mean haemoglobin concentration for the whole group increased from 6.6 +/- 0.8 g/dl, to 9.2 +/- 1.2 at 6 months and 9.7 +/- 0.7 g/dl at 1 year. Twenty-two out of 28 children reached the target haemoglobin value of 9.6 g/dl (6 mmol/dL) within a mean time of 16.5 weeks. Poor responses were due to either a premature withdrawal of treatment because of renal transplantation, or too low a dosage for the age. The study showed indeed that the dose requirement was significantly dependent on physical development: the mean dosage required to maintain haemoglobin concentration at the target value was 300 U/kg/week in children weighing less than 20 kg, 222 U/kg/week in 20-30 kg children, and 135 U/kg/week in those weighing more than 30 kg (p = 0.02). The only complication was an increase in blood pressure, observed in 43% of cases. The increase of anti-hypertensive medication was always successful in controlling blood pressure, and hospitalization was required in only one case. The improvement in general condition was obvious, and in several cases, the cognitive abilities seemed to improve. The growth deficit remained unchanged.
Service de néphrologie pédiatrique, Hôpital des Enfants-Malades, Paris.
M F
MF
Gagnadoux
C
C
Loirat
J P
JP
Berthélémé
A
A
Maisin
A
A
Kamoun
D
D
Dabout
D
D
Poisson
M
M
Broyer
D000293:Adolescent; D000740:Anemia / Q000209:etiology / Q000628:therapy*; D001066:Appetite / Q000187:drug effects; D001803:Blood Transfusion / Q000706:statistics & numerical data; D001835:Body Weight; D002648:Child; D002675:Child, Preschool; D003072:Cognition Disorders / Q000209:etiology / Q000628:therapy; D004305:Dose-Response Relationship, Drug; D004921:Erythropoietin / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D005260:Female; D005602:France; D006130:Growth Disorders / Q000209:etiology; D006454:Hemoglobins / Q000032:analysis; D006801:Humans; D006973:Hypertension / Q000139:chemically induced; D007155:Immunologic Factors / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D007223:Infant; D007676:Kidney Failure, Chronic / Q000150:complications* / Q000628:therapy; D008297:Male; D011994:Recombinant Proteins / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use; D006435:Renal Dialysis / Q000009:adverse effects; D016896:Treatment Outcome
D006454:Hemoglobins; D007155:Immunologic Factors; D011994:Recombinant Proteins; D004921:Erythropoietin
Traitement de l'anémie des enfants hémodialysés par l'érythropoïétine humaine recombinante (Eprex). Résultats de l'essai clinique multicentrique français.