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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2003-04-30

Study Completion Date

2006-01-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Kidney Transplantation

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A (With Daclizumab Therapy)

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.

Group Type EXPERIMENTAL

DT

Intervention Type BIOLOGICAL

Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response.

Daclizumab

Intervention Type DRUG

The fifth dose (1 milligram per kilogram \[mg/kg\]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).

KLH

Intervention Type BIOLOGICAL

KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.

Group B (Post Daclizumab Therapy)

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

Group Type ACTIVE_COMPARATOR

DT

Intervention Type BIOLOGICAL

Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response.

KLH

Intervention Type BIOLOGICAL

KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.

Interventions

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DT

Diphtheria and Tetanus Toxoid (DT) will be administered intramuscularly as a 1/3 dilution (0.33 flocculation units). The participants will be rechallenged with DT 6 months after Day 29 if failed to show \>=1.5 fold increase in lymphocyte proliferative response but have a humoral response.

Intervention Type BIOLOGICAL

Daclizumab

The fifth dose (1 milligram per kilogram \[mg/kg\]) of daclizumab will be administered in this study to participants who already received four doses (one dose at 1 mg/kg within 24 hours post-transplant and then every other week for 3 doses).

Intervention Type DRUG

KLH

KLH will be administered intradermally with a dose of 250 mcg for participants aged 2 to less than 12 years, and 500 mcg for participants aged 12 to 19 years. The participants will be rechallenged with KLH 6 months after Day 29 if failed to show specified increase in lymphocyte proliferative response or humoral response.

Intervention Type BIOLOGICAL

Other Intervention Names

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Zenapax

Eligibility Criteria

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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

Minimum Eligible Age

2 Years

Maximum Eligible Age

19 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No