Ignite Creation Date:
2024-05-05 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00141037
Status:
COMPLETED
Last Update Posted:
2016-11-29
First Post:
2005-08-01
Brief Title:
Steroid-Free Versus Steroid-Based Immunosuppression in Pediatric Renal Kidney Transplantation
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Randomized Multi-Center Comparative Trial of Tacrolimus wSteroids and Standard Daclizumab Induction vs a Novel Steroid-Free Tacrolimus Based Immunosuppression Protocol w Extended Daclizumab Induction in Pediatric Renal Transplantation
Status:
COMPLETED
Status Verified Date:
2016-10
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:
Over the last 40 years corticosteroids steroids have been an important part of drug regimens used to prevent organ rejection and to maintain the immune health of individuals who have received organ transplants Unfortunately the negative physical effects of steroids can be severe especially in children The purpose of this study is to determine the safety and effectiveness of a steroid-free treatment regimen for children and adolescents who have received kidney renal transplants
Detailed Description:
Corticosteroids steroids have been a cornerstone of immunosuppressive therapy for kidney renal transplantation for over 40 years However poor growth and bone loss caused by the use of steroids are devastating to pediatric kidney recipients The negative physical implications of steroid use also greatly impacts patients compliance to their prescribed steroid-containing regimens
The development of a steroid-free regimen for post-transplant pediatric patients is sorely needed This study will evaluate the safety and efficacy of a steroid-free based treatment regimen in children and adolescents who have received kidney transplants compared to a standard of care steroid-based regimen Participants in this study will be pediatric patients with end-stage kidney disease who will undergo kidney transplantation at the start of the study
Patients will participate in this study for 3 years Participants will be randomized 11 to one of two groups The study includes 23 study visits over 3 years A physical exam medication history adverse events reporting blood pressure readings growth assessment and blood collection will occur at most visits At the time of transplantation participants will have a kidney biopsy Participants will also undergo cataract screening within 4 months of transplantation
The development of a steroid-free regimen for post-transplant pediatric patients is sorely needed This study will evaluate the safety and efficacy of a steroid-free based treatment regimen in children and adolescents who have received kidney transplants compared to a standard of care steroid-based regimen Participants in this study will be pediatric patients with end-stage kidney disease who will undergo kidney transplantation at the start of the study
Patients will participate in this study for 3 years Participants will be randomized 11 to one of two groups The study includes 23 study visits over 3 years A physical exam medication history adverse events reporting blood pressure readings growth assessment and blood collection will occur at most visits At the time of transplantation participants will have a kidney biopsy Participants will also undergo cataract screening within 4 months of 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