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

This study has been completed.
Sponsor:
Information provided by:
Novo Nordisk A/S
ClinicalTrials.gov Identifier:
NCT00184769
First received: September 13, 2005
Last updated: June 28, 2012
Last verified: June 2012

September 13, 2005
June 28, 2012
January 1998
December 2005   (final data collection date for primary outcome measure)
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 ] [ Designated as safety issue: No ]
To evaluate the effect of growth hormoneon infants aged 1 to 2 years with CRI and growth retardation growth retardation despite an adequate dietary intake after 1 year of treatment.
Complete list of historical versions of study NCT00184769 on ClinicalTrials.gov Archive Site
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 [ Designated as safety issue: No ]
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 psycological development.
Not Provided
Not Provided
 
Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency (CRI) and Growth Retardation.
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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Chronic Kidney Disease
  • Chronic Renal Insufficiency
Drug: somatropin
Not Provided
Santos F, Moreno ML, Neto A, Ariceta G, Vara J, Alonso A, Bueno A, Afonso AC, Correia AJ, Muley R, Barrios V, Gómez C, Argente J. Improvement in growth after 1 year of growth hormone therapy in well-nourished infants with growth retardation secondary to chronic renal failure: results of a multicenter, controlled, randomized, open clinical trial. Clin J Am Soc Nephrol. 2010 Jul;5(7):1190-7. doi: 10.2215/CJN.07791109. Epub 2010 Jun 3.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
December 2005
December 2005   (final data collection date for primary outcome measure)

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.
Both
9 Months to 15 Months
No
Contact information is only displayed when the study is recruiting subjects
Spain
 
NCT00184769
GHCRF/E/2
No
Public Access to Clinical Trials, Novo Nordisk A/S
Novo Nordisk A/S
Not Provided
Study Director: Llanos Moreno Novo Nordisk Pharma S.A
Novo Nordisk A/S
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP