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Immunophenotyping and Functional Profiles of Peripheral Lymphocytes in Renal Transplant Recipients After T-cell Depletion With Alemtuzumab (Anti-CD52 Monoclonal Antibody)-Potential Implications for Safe Immunosuppressive Minimization


Phase 4
18 Years
65 Years
Not Enrolling
Both
Kidney Transplant

Thank you

Trial Information

Immunophenotyping and Functional Profiles of Peripheral Lymphocytes in Renal Transplant Recipients After T-cell Depletion With Alemtuzumab (Anti-CD52 Monoclonal Antibody)-Potential Implications for Safe Immunosuppressive Minimization


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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.

Outcome Description:

Blood was collected to assess peripheral blood leukocytes prior to kidney transplant, 6 months & 12 months post-transplant as follows: to obtain absolute count of circulating CD4, CD8 positive T cells, B cells & NK cells, naive & memory cells (CD45RA, CD45RO), activated T cells (CD4/CD38, CD8/CD38), regulatory cells (CD4+ CD25+). To also obtain quantification of donor specific antibody cells for class I & class II donor HLA antigens, and measurement of C-reactive protein cells(marker of inflammation). 50cc of urine also obtained for measurement of urinary cytokines & markers of inflammation.

Outcome Time Frame:

Pre-transplant, 6months & 12 months post-transplant

Safety Issue:

No

Principal Investigator

Lorenzo Gallon, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation

Authority:

United States: Institutional Review Board

Study ID:

STU00011048

NCT ID:

NCT01213329

Start Date:

February 2006

Completion Date:

April 2009

Related Keywords:

  • Kidney Transplant

Name

Location

Northwestern Memorial HospitalChicago, Illinois  60611