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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Novo Nordisk A/S · Industry
• Sex: All
• Age: 9 Months – 15 Months
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	somatropin

Timeline

• Start date: 1998-01-29
• Primary completion: 2005-12-21
• Completion: 2005-12-21
• First posted: 2005-09-16
• Last updated: 2017-02-27

Locations

20 sites across 2 countries: Portugal, Spain