Ignite Creation Date:
2024-05-05 @ 7:38 PM
Last Modification Date:
2024-10-26 @ 9:51 AM
Study NCT ID:
NCT00707759
Status:
COMPLETED
Last Update Posted:
2015-11-10
First Post:
2008-06-26
Brief Title:
Steroid Withdrawal in Pediatric Renal Transplant Impact on Growth Bone Metabolism and Acute Rejection
Sponsor:
Fondo Nacional de Desarrollo Científico y Tecnológico Chile
Organization:
Fondo Nacional de Desarrollo Científico y Tecnológico Chile
Study Overview
Official Title:
Multicenter Open-Label Randomized Study on Steroid-Free Immunosuppression in Comparison With Daily Steroid Therapy in Pediatric Renal Transplant Impact on Growth Bone Metabolism and Acute Rejection
Status:
COMPLETED
Status Verified Date:
2015-10
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:
The present study investigates the safety and efficacy of steroid withdrawal at six days post-transplant in pediatric renal recipients under concomitant immunosuppression based on antibodies anti IL2 interleukin 2 Tacrolimus TAC and Mycophenolate Mofetil MMF To investigate the impact of this protocol in growth bone metabolism insulin- sensitivity and evaluate the expression of IL17 interleukin 17 and mRNA FOXP3 messenger ribonucleic acid forkhead box protein 3 as early markers of acute rejection blood urine and renal biopsy
HypothesisSteroid withdrawal in renal pediatric transplant patients improves growth and bone metabolism without increasing the risk of acute rejection The expression of FoxP3IL17 in urine cells could be an early molecular markers of acute rejection
HypothesisSteroid withdrawal in renal pediatric transplant patients improves growth and bone metabolism without increasing the risk of acute rejection The expression of FoxP3IL17 in urine cells could be an early molecular markers of acute rejection
Detailed Description:
The intention of this investigation is to evaluate a prospective immunosuppressive protocol based on antibodies anti IL-2 Ac-IL-2 Tacrolimus TAC and Mycophenolate Mofetil MMFand withdrawal steroids in renal transplant and to compare with a steroid-based protocol
Objectives
1 To evaluate growth and the impairment in the GHIGF growth hormoneinsulin like growth factor axis
2 To determine the impact of steroids on bone metabolism biochemical parameters DXA and pQCT
3 To determine the steroid effect on metabolic factors dyslipidemia insulin- sensitivity and arterial hypertension
4 To determine acute rejection incidence protocol renal biopsy
5 To evaluate the expression of IL-17 and mRNA FoxP3 as early markers of acute rejection blood urine and renal biopsy
Two treatment regimes Armswill be compared in randomized form in the course of 12 months after transplantation
Arm A TAC MMF withdrawal of steroids over a six-days following randomization
Arm B TAC MMF prednisolone see scheduleday
Objectives
1 To evaluate growth and the impairment in the GHIGF growth hormoneinsulin like growth factor axis
2 To determine the impact of steroids on bone metabolism biochemical parameters DXA and pQCT
3 To determine the steroid effect on metabolic factors dyslipidemia insulin- sensitivity and arterial hypertension
4 To determine acute rejection incidence protocol renal biopsy
5 To evaluate the expression of IL-17 and mRNA FoxP3 as early markers of acute rejection blood urine and renal biopsy
Two treatment regimes Armswill be compared in randomized form in the course of 12 months after transplantation
Arm A TAC MMF withdrawal of steroids over a six-days following randomization
Arm B TAC MMF prednisolone see scheduleday
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