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.
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
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