Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00184769
Status:
COMPLETED
Last Update Posted:
2017-02-27
First Post:
2005-09-13
Brief Title:
Growth Hormone Treatment in Infants Aged 1 to 2 Years With Chronic Renal Insufficiency CRI and Growth Retardation
Sponsor:
Novo Nordisk AS
Organization:
Novo Nordisk AS
Study Overview
Official Title:
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
Status Verified Date:
2017-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This trial is conducted in Europe Objectives 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 123 to 24 months suffering chronic renal insufficiency Glomerular Filtration Rate less than 60 mlmin173 m2 and growth failure and undergoing conservative treatment or peritoneal dialysis Include the key inclusion and exclusion criteria
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 123 to 24 months suffering chronic renal insufficiency Glomerular Filtration Rate less than 60 mlmin173 m2 and growth failure and undergoing conservative treatment or peritoneal dialysis Include the key inclusion and exclusion criteria
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None