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

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-06-30

Study Completion Date

2012-05-31

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.

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Detailed Description

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Conditions

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Disorder Related to Renal Transplantation

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Campath 1-H

Group Type EXPERIMENTAL

Campath-1H

Intervention Type DRUG

two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant

Interventions

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Campath-1H

two intravenous 20mg/m2/doses, the first on the day of transplant and the second dose on day 1 post transplant

Intervention Type DRUG

Other Intervention Names

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Alemtuzumab

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

Minimum Eligible Age

18 Months

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No