Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01213329
Recruitment Status : Terminated
First Posted : October 4, 2010
Results First Posted : July 4, 2011
Last Update Posted : October 13, 2017
American Society of Transplant Surgeons
Information provided by (Responsible Party):
Lorenzo Gallon, Northwestern University

Brief 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. 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 or disease Intervention/treatment Phase
Kidney Transplant Drug: Alemtuzumab Phase 4

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 52 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

Phase 1: 50 subjects were to receive study intervention. If any subjects demonstrated persistent donor specific unresponsiveness at the 12 month post-transplant time point, they would proceed into Phase 2. In that phase, the unresponsive subjects would have been randomized to one of three arms that would modify their standard of care immunosuppression.

None of the 50 subjects from Phase 1 demonstrated persistent donor specific unresponsiveness, therefore, phase 2 was never started.

Masking: None (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
Study Start Date : February 2006
Actual Primary Completion Date : April 2009
Actual Study Completion Date : April 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Alemtuzumab
U.S. FDA Resources

Arm Intervention/treatment
Experimental: Phase I: Alemtuzumab
During Phase I Portion: 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®

Primary Outcome Measures :
  1. 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 ]
    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 :
  1. Identify Development of Donor-specific Hyperactivity [ Time Frame: Pre-transplant, 6mo & 12mo post-transplant ]
    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.

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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01213329

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

Responsible Party: Lorenzo Gallon, Associate Professor of Medicine & Surgery, Northwestern University Identifier: NCT01213329     History of Changes
Other Study ID Numbers: STU00011048
First Posted: October 4, 2010    Key Record Dates
Results First Posted: July 4, 2011
Last Update Posted: October 13, 2017
Last Verified: September 2017

Additional relevant MeSH terms:
Antineoplastic Agents