Ignite Creation Date:
2024-05-05 @ 4:38 PM
Last Modification Date:
2024-10-26 @ 9:22 AM
Study NCT ID:
NCT00284531
Status:
TERMINATED
Last Update Posted:
2015-10-16
First Post:
2006-01-31
Brief Title:
Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients
Sponsor:
Baylor College of Medicine
Organization:
Baylor College of Medicine
Study Overview
Official Title:
Use of Zenapax Daclizumab for the Prevention of Primary Acute Cardiac Rejection in Children and Adolescents Ind Number 10100
Status:
TERMINATED
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Slow enrollment
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This protocol is designed to obtain information on the drug levels metabolism and safety of daclizumab ZenapaxR in children and adolescents undergoing cardiac transplantation In addition to the drug safety and metabolism information the number and severity of rejection episodes in patients undergoing cardiac transplantation using the standard immunosuppressive drugs plus daclizumab will be compared with patients who have previously undergone cardiac transplantation at the Baylor College of Medicine and received the same standard immunosuppressive drugs without daclizumab
Detailed Description:
Initial studies in renal and recent studies in adult cardiac transplant patients have shown ZenapaxR to be both efficacious and safe when used in several different dosing schedules Little data is available regarding pharmacokinetics safety and appropriate dosing in pediatric heart transplant patients Yet this ever-increasing group of patients presents a significant challenge for the prevention of primary rejection and the appropriate maintenance of immunosuppression Induction of long term allograft acceptance through peripheral tolerance has been shown in animal models to be more easily induced in young animals Once established however allograft rejection and immunologic responses in the young are quite vigorous This dichotomy makes young allograft recipients a particularly attractive population for the study of immune modulators targeted at preventing proliferative expansion of alloreactive T cell clones This is precisely the mode of action of anti-IL2R monoclonal reagents such as ZenapaxR
Although some pharmacokinetic data have been generated in adult heart transplant patients on multidrug immunosuppressive regimens including both ZenapaxR and mycophenolate mofetil MMF detailed pharmacokinetic data on this combination in multidrug immunosuppressive regimens is not available for pediatric heart transplant subjects
Objectives
Determination of pharmacokinetics of ZenapaxR in pediatric patients receiving a uniform multidrug immunosuppressive regimen for primary induction
Determine whether there are any unusual drug interactions peculiar to the pediatric population that would require dosing modification
Secondary objectives
Investigate long term effects of ZenapaxR containing induction regimen on pediatric patients
Although some pharmacokinetic data have been generated in adult heart transplant patients on multidrug immunosuppressive regimens including both ZenapaxR and mycophenolate mofetil MMF detailed pharmacokinetic data on this combination in multidrug immunosuppressive regimens is not available for pediatric heart transplant subjects
Objectives
Determination of pharmacokinetics of ZenapaxR in pediatric patients receiving a uniform multidrug immunosuppressive regimen for primary induction
Determine whether there are any unusual drug interactions peculiar to the pediatric population that would require dosing modification
Secondary objectives
Investigate long term effects of ZenapaxR containing induction regimen on pediatric patients
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 |
|---|---|---|---|
| H-18397 | OTHER | Baylor College of Medicine | None |