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

NCT ID: NCT00184769

Last Updated: 2017-02-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 1998-01-29
• Study Completion Date: 2005-12-21

Brief Summary

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.

Conditions

Chronic Kidney Disease; Chronic Renal Insufficiency

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

somatropin

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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

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.

• Minimum Eligible Age: 9 Months
• Maximum Eligible Age: 15 Months
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novo Nordisk A/S

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Global Clinical Registry (GCR, 1452)

Role: STUDY_DIRECTOR

Novo Nordisk A/S

Locations

Novo Nordisk Investigational Site

Coimbra, , Portugal

Novo Nordisk Investigational Site

Lisbon, , Portugal

Novo Nordisk Investigational Site

Lisbon, , Portugal

Novo Nordisk Investigational Site

Porto, , Portugal

Novo Nordisk Investigational Site

Badajoz, , Spain

Novo Nordisk Investigational Site

Barakaldo, , Spain

Novo Nordisk Investigational Site

Esplugues Llobregat, , Spain

Novo Nordisk Investigational Site

Lugo, , Spain

Novo Nordisk Investigational Site

Madrid, , Spain

Novo Nordisk Investigational Site

Madrid, , Spain

Novo Nordisk Investigational Site

Madrid, , Spain

Novo Nordisk Investigational Site

Málaga, , Spain

Novo Nordisk Investigational Site

Oviedo, , Spain

Novo Nordisk Investigational Site

Pamplona, , Spain

Novo Nordisk Investigational Site

San Sebastián, , Spain

Novo Nordisk Investigational Site

Santa Cruz de Tenerife, , Spain

Novo Nordisk Investigational Site

Santander, , Spain

Novo Nordisk Investigational Site

Santiago de Compostela, , Spain

Novo Nordisk Investigational Site

Seville, , Spain

Novo Nordisk Investigational Site

Zaragoza, , Spain

Countries

Portugal; Spain

References

Santos F, Moreno ML, Neto A, Ariceta G, Vara J, Alonso A, Bueno A, Afonso AC, Correia AJ, Muley R, Barrios V, Gomez 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.

Reference Type: DERIVED

PMID: 20522533 (View on PubMed)

Related Links

http://novonordisk-trials.com

Clinical Trials at Novo Nordisk

Other Identifiers

GHCRF/E/2

Identifier Type: -

Identifier Source: org_study_id