- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT00184769
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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Badajoz, España, 06080
- Novo Nordisk INvestigational Site
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Baracaldo, España, 48903
- Novo Nordisk INvestigational Site
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Esplugues Llobregat, España, 08950
- Novo Nordisk INvestigational Site
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Lugo, España, 27004
- Novo Nordisk INvestigational Site
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Madrid, España, 28009
- Novo Nordisk INvestigational Site
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Madrid, España, 28046
- Novo Nordisk INvestigational Site
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Madrid, España, 28041
- Novo Nordisk INvestigational Site
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Málaga, España, 29011
- Novo Nordisk INvestigational Site
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Oviedo, España, 33006
- Novo Nordisk INvestigational Site
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Pamplona, España, 31008
- Novo Nordisk INvestigational Site
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San Sebastián, España
- Novo Nordisk INvestigational Site
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Santa Cruz de Tenerife, España, 38010
- Novo Nordisk INvestigational Site
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Santander, España, 39008
- Novo Nordisk INvestigational Site
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Santiago de Compostela, España, 15705
- Novo Nordisk INvestigational Site
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Sevilla, España, 41013
- Novo Nordisk INvestigational Site
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Zaragoza, España, 50009
- Novo Nordisk INvestigational Site
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Coimbra, Portugal, 3000-075
- Novo Nordisk INvestigational Site
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Lisboa, Portugal, 1649-035
- Novo Nordisk INvestigational Site
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Lisboa, Portugal, 1160-045
- Novo Nordisk INvestigational Site
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Porto, Portugal, 4200-319
- Novo Nordisk INvestigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Ninguno (etiqueta abierta)
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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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
Periodo de tiempo: after 1 year of treatment
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after 1 year of treatment
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Medidas de resultado secundarias
Medida de resultado |
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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
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Colaboradores e Investigadores
Patrocinador
Publicaciones y enlaces útiles
Enlaces Útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- GHCRF/E/2
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