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

• Status: Completed
• Trial end date: 2006-01-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Daclizumab; Immunoglobulin G

Criteria

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