A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
Completed · Phase 4
Conditions studied: Kidney Transplantation
In brief
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.
Key facts
- Study ID
- NCT02576145
- Run by
- Hoffmann-La Roche
- People needed
- 11
- Starts
- 2003-04-01
- Expected to finish
- 2006-01-01
- Last updated by the study team
- 2016-01-13
Who can join
Age: 2 and older, up to 19. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- 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
Where it is running
- Study site — Los Angeles, California, United States
- Study site — Los Angeles, California, United States
- Study site — Indianapolis, Indiana, United States
- Study site — Kansas City, Missouri, United States
- Study site — Portland, Oregon, United States
Full record on ClinicalTrials.gov
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