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

Roche

Status and phase: Completed; Phase 4

Conditions: Kidney Transplantation

Treatments: Drug: Daclizumab; Biological: KLH; Biological: DT

Study type: Interventional

Funder types: Industry

Identifiers

NCT02576145

PA16215

Details and patient eligibility

About

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.

Enrollment: 11 patients

Sex: All

Ages: 2 to 19 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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11 participants in 2 patient groups

Group A (With Daclizumab Therapy)

Experimental group

Description:

Participants who were receiving a full course of 5 doses of daclizumab (1 milligram per kilogram \[mg/kg\]) with Day 1 vaccine administered immediately prior to the fifth dose.

Treatment:

Drug: Daclizumab

Biological: DT

Biological: KLH

Group B (Post Daclizumab Therapy)

Active Comparator group

Description:

Participants who completed a full course of daclizumab therapy in the previous 4 to 18 months.

Treatment:

Biological: DT

Biological: KLH