Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients

Cardiac Transplantation Clinical Trial

Official title: Use of Zenapax (Daclizumab) for the Prevention of Primary Acute Cardiac Rejection in Children and Adolescents. Ind Number: 10100

Status Terminated

Clinical Trial Summary

This protocol is designed to obtain information on the drug levels, metabolism, and safety of daclizumab (Zenapax(R)) 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.

Clinical Trial Description

Initial studies in renal and recent studies in adult cardiac transplant patients have shown Zenapax(R) 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 Zenapax(R).

Although some pharmacokinetic data have been generated in adult heart transplant patients on multidrug immunosuppressive regimens including both Zenapax(R) 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 Zenapax(R) 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 Zenapax(R) containing induction regimen on pediatric patients. ;

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiac Transplantation

• NCT number: NCT00284531
• Study type: Interventional
• Source: Baylor College of Medicine
• Status: Terminated
• Phase: Phase 1/Phase 2
• Start date: October 2003
• Completion date: May 2007