Phase 4
Completed N=11
A Study to Assess Immune Response in Pediatric Kidney Transplant Recipients Treated With Daclizumab (Zenapax)
Source: ClinicalTrials.gov NCT02576145 ↗Enrolled (actual)
11
Serious AEs
45.5%
Results posted
Jan 2016
Primary outcomePrimary: Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization — 2; 2 participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants Who Developed a Positive Antibody Response (IgG) to Keyhole Limpet Hemocyanin (KLH) Immunization |
2; 2 | — |
| SECONDARY Number of Participants Who Developed a Positive Cellular Response to KLH Immunization |
1; 4 | — |
| SECONDARY Number of Participants Who Developed Both a Positive Antibody Response and a Positive Cellular Response to KLH Immunization |
1; 1 | — |
| SECONDARY Number of Participants Who Developed a Positive Humoral Response to Tetanus Toxoid (TT) |
3; 3 | — |
| SECONDARY Number of Participants Who Developed a Positive Cellular Response to Tetanus Toxoid (TT) |
2; 3 | — |
| SECONDARY Number of Participants Who Developed a Positive Antibody Response to KLH and Positive Cellular Responses to Both KLH and TT Immunizations |
0; 1 | — |
| SECONDARY Number of KLH Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Response to KLH Immunization |
0; 0 | — |
| SECONDARY Number of Tetanus Cellular Nonresponders Who Were Rechallenged and Mounted a Cellular Tetanus Response |
0; 0 | — |
| SECONDARY Geometric Mean Antibody Concentrations for KLH (IgM and IgG) and TT (IgG) |
— | — |
| SECONDARY Mean Percent Expression of 2A3/CD25+ Antibody |
0.10; 9.44; 0.12; 8.53; 0.06; 10.18 | — |
| SECONDARY Mean Percent Expression of CD3, CD4, and CD8 |
76.97; 79.50; 78.70; 77.25; 79.82; 78.80 | — |
| SECONDARY Mean Percent Expression of HLA-DR+, CD45RO+ and CD45RA+ |
2.58; 5.80; 5.04; 5.10; 4.16; 4.55 | — |
| SECONDARY Percentage of Participants With Positive Antibody Response to KLH Immunization at Month 6 |
— | — |
| SECONDARY Number of KLH Antibody Nonresponders Who Underwent Rechallenge and Mounted a KLH Antibody Response |
1; 1 | — |
| SECONDARY Number of Participants With a Positive Delayed Type Hypersensitivity (DTH) Response After KLH Immunization |
0; 1 | — |
| SECONDARY Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE) |
6; 4; 3; 2 | — |
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT02576145). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.