Ignite Creation Date:
2024-05-05 @ 10:00 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004429
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Randomized Study of Recombinant Human Growth Hormone in Patients on Chronic Hemodialysis or Peritoneal Dialysis
Sponsor:
FDA Office of Orphan Products Development
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2007-10
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:
OBJECTIVES
I Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients
I Assess the clinical safety and long term effects of recombinant human growth hormone on a defined range of nutritional indices in malnourished chronic hemodialysis and continuous ambulatory peritoneal dialysis patients
Detailed Description:
PROTOCOL OUTLINE This is a randomized double blind placebo-controlled cross-over study
Prior to randomization each patients protein and calorie intake is assessed and optimized as possible Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months At the end of this 6 month period patients undergo a 4 week washout period After the washout period patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period
Prior to randomization each patients protein and calorie intake is assessed and optimized as possible Patients are randomized to receive either placebo or recombinant human growth hormone subcutaneously every other day for 6 months At the end of this 6 month period patients undergo a 4 week washout period After the washout period patients are crossed-over to the alternate regimen for an additional 6 months followed by another 4 week washout period
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| VUMC-FDR000943 | None | None | None |