Ignite Creation Date:
2024-05-05 @ 4:42 PM
Last Modification Date:
2024-10-26 @ 9:23 AM
Study NCT ID:
NCT00296348
Status:
COMPLETED
Last Update Posted:
2015-06-26
First Post:
2006-02-23
Brief Title:
Comparing Efficacy and Safety of Steroid Withdrawal With Tacrolimus and MMF With Induction in Children After Kidney Transplantation
Sponsor:
Astellas Pharma Inc
Organization:
Astellas Pharma Inc
Study Overview
Official Title:
An Open Randomised Multicentre Clinical Study to Investigate the Safety and Efficacy of Steroid Withdrawal With Tacrolimus Mycophenolate Mofetil and Daclizumab Against Tacrolimus Mycophenolate Mofetil and Steroids in Children After Kidney Transplantation
Status:
COMPLETED
Status Verified Date:
2015-06
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:
TWIST
Brief Summary:
The primary objective of this study is to investigate the impact of early corticosteroid withdrawal in paediatric renal transplant patients on growth expressed as change in height standard deviation score SDS from baseline to end of study as the primary endpoint The expected advantages are reduced growth suppression lower incidence of arterial hypertension and post transplant diabetes mellitus PTDM and improved lipid metabolism expressed by lower serum lipid values
Detailed Description:
Comparing efficacy safety of steroid withdrawal with tacrolimus mycophenolate mofetil MMF with induction in children after kidney transplantation
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| PRG-EC-0243 | OTHER | Astellas Pharma Europe Ltd | None |