Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

Study Overview
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Brief Summary
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The purpose of this study is to determine whether Campath-1H induction and the associated lymphocyte depletion will permit long-term rejection-free renal allograft survival in the absence of ongoing corticosteroid administration.

Official Title
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Campath-1H Induction to Allow Steroid Free Immunosuppression in Pediatric Renal Transplantation

Conditions
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Disorder Related to Renal Transplantation

Intervention / Treatment
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* Drug: Campath-1H


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants must be a single-organ recipient (kidney only) Participants who are receiving their first living donor or deceased donor transplant Exclusion Criteria: Participants who are recipients of HLA-identical living-donor renal transplants Participants with a PRA value > 10% within 30 days prior to the transplant Participants who have received a multi-organ transplant Participants who are who are positive for hepatitis C, hepatitis B surface antigen or HIV Participants who have received an investigational drug within 6 weeks of study entry Participants who have a previous history of, or who currently have, malignancies and/or lymphoma Participants who have received corticosteroids within three months of transplantation Participants who are 3rd transplant recipients Female participants who are pregnant or lactating. Fertile female participants who are sexually active must agree to use an acceptable method of birth control during the study

Ages Eligible for Study
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Minimum Age: 18 Months
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Campath 1-H<br>Campath 1-H | Drug: Campath-1H<br>* two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant<br>* Other names: Alemtuzumab;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Graft Rejection |  | at 1, 3, 6, 12, and 24 months | 
| Participant Graft Survival |  | at 6, 12, and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Estimated Glomerular Filtration Rate (EGFR) | Measure of renal function | at 1, 6, 12 and 24 months | 
| Number of Participants With Infection | Cytomegalovirus(CMV), Epstein Barr Virus (EBV) BK Virus (BK) | up to 24 months | 
| Number of Participants With Malignancy |  | up to 24 months | 
| Growth Post-transplant Reported by Height Z Score | A z-score (aka, a standard score) indicates how many standard deviations an element is from the mean, in this case, height. A score of '0' is equal to the mean, a score less than 0 is less than the mean, and a score greater than 0 is greater than the mean. | up to 24 months | 
| Number of Participants With Hypertension |  | up to 24 months | 
| Number of Participants With Hyperlipidemia |  | up to 24 months | 
| Participant Survival |  | at 6, 12, and 24 months | 
| Number of Participant With Diabetes Mellitus |  | up to 24 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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living or deceased donor renal transplant recipient