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

• Status: Terminated
• Trial end date: 2012-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Wisconsin, Madison
• Treatments: Alemtuzumab

Criteria

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