Use of Daclizumab for the Prevention of Allograft Rejection in Pediatric Heart Transplant Patients
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|ClinicalTrials.gov Identifier: NCT00284531|
Recruitment Status : Terminated (Slow enrollment)
First Posted : February 1, 2006
Last Update Posted : October 16, 2015
|Condition or disease||Intervention/treatment||Phase|
|Cardiac Transplantation||Drug: Daclizumab||Phase 1 Phase 2|
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.
- 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.
- Investigate long term effects of Zenapax(R) containing induction regimen on pediatric patients.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Use of Zenapax (Daclizumab) for the Prevention of Primary Acute Cardiac Rejection in Children and Adolescents. Ind Number: 10100|
|Study Start Date :||October 2003|
|Primary Completion Date :||May 2007|
|Study Completion Date :||May 2007|
- Drug levels at scheduled time points
- Receptor saturation at scheduled time points
- Number of rejection episodes in 1 year
- Changes in T cell subsets over observation period
- Numbers of bacterial and opportunistic infections
- Evidence for autoimmune disease over observation period
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00284531
|United States, Texas|
|Baylor College of Medicine|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Howard M Rosenblatt, MD||Baylor College of Medicine|