Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.
Status:
Completed
Trial end date:
2005-12-21
Target enrollment:
Participant gender:
Summary
This trial is conducted in Europe. Objective(s): To evaluate the effect of human growth
hormone on infants aged 1 to 2 years with chronic renal insufficiency (CRI) and growth
retardation despite an adequate dietary intake.
Trial Design: This is an open, parallel group clinical trial with a duration of one year, in
which period 50% of patients will receive GH treatment and the other 50% will act as a
control group, without treatment.
Trial Population: The trial will involve a total of 16 infants aged from 12±3 to 24 months
suffering chronic renal insufficiency (Glomerular Filtration Rate less than 60 ml/min/1.73
m2), and growth failure and undergoing conservative treatment or peritoneal dialysis. Include
the key inclusion and exclusion criteria.