Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

This study has been terminated.
Sponsor:
Collaborator:
American Society of Transplant Surgeons
Information provided by (Responsible Party):
Lorenzo Gallon, Northwestern University
ClinicalTrials.gov Identifier:
NCT01213329
First received: September 30, 2010
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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. We will look for these cells using a number of laboratory tests; It will require the subjects to each give 65mL of blood at each of the 3 visits that occur during phase 1. Up to 12 subjects will be chosen from phase 1 to participate in phase 2 depending on lab results.

In phase 2, subjects will be randomized to one of the three following groups:

Group one: Continue normal immunosuppression with tacrolimus and Cellcept® (control group)

Group two: Cellcept® will be tapered down to 70% in three months. Tacrolimus will be continued at the same dosage.

Group three: Tacrolimus will be reduced to 70% in three months. Cellcept® will be continued at the same dosage.

There will be an analysis of these cells at different time point, pre and post kidney transplant. The data collection will allow us to study the stability over time of particular phenotypes (cell structures) and T cell function. We will also evaluate how the two different "minimizing protocols" effect the cell structure. Results from laboratory testing may allow us to define certain criteria that can be broadly applied in solid organ transplant recipients. This may allow for safe reduction of the anti-rejection medication that transplant recipients receive.


Condition Intervention Phase
Kidney Transplant
Drug: Alemtuzumab
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients. [ Time Frame: Pre-transplant, 6months & 12 months post-transplant ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Identify Development of Donor-specific Hyperactivity [ Time Frame: Pre-transplant, 6mo & 12mo post-transplant ] [ Designated as safety issue: No ]
    Identify, by studying recipients for development of donor specific hyperactivity and through immunopathologic analysis of renal allograft biopsies, immunologically stable renal transplant patients in whom immunosuppression can be safely minimized.


Enrollment: 52
Study Start Date: February 2006
Study Completion Date: April 2009
Primary Completion Date: April 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Alemtuzumab
Each kidney transplant recipient received one 30mg dose (IV push)of Alemtuzmab in the operating room per Standard of Care.
Drug: Alemtuzumab
All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.
Other Name: Campath 1-H®

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01213329

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
American Society of Transplant Surgeons
Investigators
Principal Investigator: Lorenzo Gallon, MD Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
  More Information

No publications provided

Responsible Party: Lorenzo Gallon, Associate Professor of Medicine & Surgery, Northwestern University
ClinicalTrials.gov Identifier: NCT01213329     History of Changes
Other Study ID Numbers: STU00011048
Study First Received: September 30, 2010
Results First Received: May 3, 2011
Last Updated: April 18, 2013
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Alemtuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014