Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-24 @ 10:52 PM
NCT ID:
NCT00184769
Eligibility Criteria:
Inclusion Criteria:
* Patients will be infants of both sexes aged 12 ± 3 months with chronic renal insufficiency and growth retardation.
* To be included in the trial, patients must meet all of the following inclusion criteria a.)-c.):
* 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
Exclusion Criteria:
* 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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
9 Months
Maximum Age:
15 Months
Study:
NCT00184769
Study Brief:
Protocol Section:
NCT00184769