Trial Information

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

Status: Completed

Protocol Number: PA16215

Sponsor: Hoffmann-La Roche Inc

Company Division: Pharmaceutical

Official Scientific Title: An open-label study to determine whether Zenapax impairs the ability to elicit a primary immune response in children who have received a kidney transplant

Brief Summary: This study will assess whether Zenapax impairs the ability of children receiving a kidney transplant to elicit a primary immune response. The anticipated time on study treatment is 3-12 months, and the target sample size is <100 individuals. Target sample size is 82.

Study Phase: IV

Study Design / Study Details:

  • Purpose: Treatment
  • Allocation: Non-Randomized
  • Masking: Open Label
  • Control: Uncontrolled
  • Assignment: Parallel
  • Endpoints: Safety/Efficacy

Study Type:

Interventional

Condition: Kidney Transplantation

Intervention Type: Drug

Intervention Name: daclizumab[Zenapax]

Primary Outcome: 1. Efficacy: Evaluation of tetanus and keyhole limpet hemocyanin (KLH) antibodies; detection of cellular responses to tetanus and KLH antibodies

Key Secondary Outcomes: 1. Safety: Weight, vital signs, and adverse events

Inclusion Criteria:

  • primary renal transplant recipients between 2 and 19 years of age;
  • receiving or have received Zenapax in the previous 4-18 months;
  • receiving or have received Zenapax <24 hours pretransplant and additional courses twice a 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.

Gender: Males or Females

Age Limits: Min: 2 Years Max: 19 Years

Accepts Healthy Volunteers: No

Trial Registration Date: 05/23/2005

Date Last Updated: 08/18/2008

Link To Trial Results

Contact:

Research Site:
Located In:
Kansas City, MO 64114
Telephone: 973-235-5000 or 800-526-6367

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Trial listings updated: August 20, 2008 at 2:16:59 PM


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