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

University of Wisconsin (UW)

Status and phase

Terminated

Phase 2

Phase 1

Conditions

Disorder Related to Renal Transplantation

Treatments

Drug: Campath-1H

Study type

Interventional

Funder types

Other

Identifiers

NCT00167661

H-2003-0493 (Other Identifier)

2011-0661

SMPH/PEDIATRICS/PEDIATRICS (Other Identifier)

A536758 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

33 patients

Sex

All

Ages

18 months to 18 years old

Volunteers

No Healthy Volunteers

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