Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: December 21, 2005

Interventions

  • Drug: somatropin

Clinical Trial Outcome Measures

Primary Measures

  • To evaluate the effect of growth hormone on infants aged 1 to 2 years with CRI and growth retardation growth retardation despite an adequate dietary intake
    • Time Frame: after 1 year of treatment

Secondary Measures

  • Secondary objectives are to assess the safety of rhGH treatment in these infants. Safety assessment will include evaluation of renal function, Bone, IGF-I, IGFBP3 and psychological development

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 9 Months

Maximum Age: 15 Months

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Novo Nordisk A/S
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Global Clinical Registry (GCR, 1452), Study Director, Novo Nordisk A/S

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