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

Phase 1/Phase 2
18 Months
19 Years
Not Enrolling
Renal Transplantation

Thank you

Trial Information

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

Inclusion Criteria:

1. Male or female subjects, aged 18 months - 18 years inclusive.

2. Subjects must be a single-organ recipient (kidney only).

3. Subjects who are receiving their first living donor or deceased donor transplant.

Exclusion Criteria:

- 1. Subjects who are recipients of HLA-identical living-donor renal transplants. 2.
Subjects with a PRA value > 10% within 30 days prior to the transplant. 3. Subjects
who have received a multi-organ transplant. 4. Subjects who are who are positive for
hepatitis C, hepatitis B surface antigen or HIV.

5. Subjects who have received an investigational drug within 6 weeks of study entry.

6. Subjects who have a previous history of, or who currently have, malignancies
and/or lymphoma.

7. Subjects who have received corticosteroids within three months of transplantation.

8. Subjects who are 3rd transplant recipients. 9. Female subjects who are
pregnant or lactating. Fertile female subjects who are sexually active must agree to
use an acceptable method of birth control during the study.

Type of Study:


Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The incidence of graft rejection and graft loss

Outcome Time Frame:

at 1, 3, 6, 12, and 24 months

Safety Issue:


Principal Investigator

Sharon M Bartosh, MD

Investigator Role:

Study Chair

Investigator Affiliation:

University of Wisconsin, Madison


United States: Food and Drug Administration

Study ID:




Start Date:

June 2004

Completion Date:

May 2014

Related Keywords:

  • Renal Transplantation
  • living or deceased donor renal transplant recipient



University of Wisconsin Hospital and Clinics Madison, Wisconsin  53792-0001