Overview

Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

Status:
Terminated

Trial end date:
2009-04-01

Target enrollment:
0

Participant gender:
All

Summary

The purpose of this study is to check the T and B cells of the immune system in 50 newly transplanted patients whom have received a kidney (50 recipients and 50 donors totaling 100 anticipated participants). This will be done to see how the Standard of Care (SOC) anti-rejection medication, Alemtuzumab (Campath 1-H®) affects these cells- Campath 1-H® reduces the number of T cells produced by one's body.

Phase:

Phase 4

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Northwestern University

Collaborator:

American Society of Transplant Surgeons

Treatments:

Alemtuzumab

Criteria

Inclusion Criteria:

1. Adult subjects between ages 18-65 years old of either gender

2. Recipients have an available ABO compatible living donor for transplant

3. Subjects are listed to be a single-organ transplant recipient (kidney only)

4. Subjects have the ability to provide informed consent

Exclusion Criteria:

1. Subjects have panel reactive antibody greater than 35%

2. Subjects have the potential to have a high recurrence rate of their primary renal
disease (i.e. Focal Segmental Glomerulonephritis )

3. Subjects who have a history of Hepatitis C

4. Subjects who have had a previous organ transplant

5. Subjects are unable to fully understand the purpose of the study, thereby unable to
give a fully informed consent

6. Subjects with a positive lymphocytotoxic crossmatch using donor lymphocytes and
recipient serum

7. Subjects who are pregnant or nursing

8. Subjects who, due to the existence of a surgical, medical or psychiatric condition,
other than the current transplant, which in the opinion of the investigator, precludes
enrollment into this trial.