Chronic Kidney Disease Clinical Trial
Official title:
Open Randomized Trial Examining the Growth and Safety Effects of Treatment With Recombinant Growth Hormone on Infants Aged 1 to 2 Years With Growth Retardation Secondary to Chronic Renal Insufficiency
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.
n/a
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