Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novo Nordisk A/S
Age
0–1
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
a.) Male or female infants with a chronological age of 12 ± 3 months
b.) Chronic renal insufficiency with Glomerular Filtration Rate less than 60 ml/min./1.73m2, according to the method used routinely in each participating center
c.) Growth retardation documented at the start of the trial, according to the following criteria: Length less than -2 SDS by chronological age and sex and linear growth velocity \<P50 according to the Hernández standards and to Lubchenko in the case of infants born prematurely (\<37 weeks)
Conservative treatment or chronic peritoneal dialysis
Euthyroid
The parent or guardian must give informed consent to the child's participation in the study before any trial related activities. Trial related activities are any procedures that would not have been performed during the normal management of the subject
Optimal nutritional management criteria met
Appropriate metabolic control for severe hyperparathyroidism, hydroelectrolyte balance, acid-base balance and calcium-phosphorus balance
You may not be if
Any primary endocrinological disorder and severe renal osteodystrophy.Other causes, apart from CRI, giving rise to growth retardation.Hydrocephalus.
Known or suspected allergy to the trial product or related products.
Treatment with corticosteroids within the last six months.
Renal disease due to the Fanconi syndrome or to oxalosis (except if not under dialysis).
Known or suspected malignancy.
Clareo Health | Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.
