A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)

Status:	Completed
Conditions:	Renal Impairment / Chronic Kidney Disease
Therapuetic Areas:	Nephrology / Urology
Healthy:	No
Age Range:	2 - 19
Updated:	4/21/2016
Start Date:	April 2003
End Date:	January 2006

Immune Response to Neoantigen and Recall Antigen in Pediatric Renal Transplant Recipients Treated With the IL-2R Alfa Monoclonal Antibody, Daclizumab (Zenapax®)

This study will assess whether daclizumab impairs the ability of children receiving a kidney
transplant to elicit a primary immune response. The anticipated time on study treatment is 1
day, and the target sample size is 82 individuals.

Inclusion Criteria:

- Primary renal transplant recipients between 2 and 19 years of age

- Receiving or have received daclizumab in the previous 4-18 months

- Receiving or have received daclizumab less than (<) 24 hours pretransplant and
additional courses every other week

- Single organ recipients (kidney only)

- Previous vaccination with tetanus toxoid (TT) prior to transplant

- Receiving a maintenance immunosuppression regimen of a calcineurin inhibitor,
mycophenolate mofetil, and prednisone (or equivalent corticosteroid)

Exclusion Criteria:

- Received intravenous gamma globulin or a TT vaccination since transplant

- Experienced rejection within 3 months of receiving study vaccinations and/or treated
with lymphocyte preparation or methylprednisolone to reverse suspected acute
rejection within 3 months of receiving study vaccinations

- Received any vaccine within 30 days of receiving study vaccinations

- Received plasmapheresis treatment or growth hormone treatment since transplant

We found this trial at

sites

Clinical Trial Facility in Portland Oregon

Portland, Oregon

from

Portland, OR