Clinical trial NCT01213329: Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: Kidney Transplant
Lead sponsor: Northwestern University
Sponsor class: OTHER
Collaborators: name: American Society of Transplant Surgeons
First posted: 2010-10-04
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: TREATMENT

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.

Detailed description: 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.

Eligibility 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.

Primary outcomes:
measure: The Effect of T Cell Depletion on Phenotypic & Functional Profiles of Peripheral Blood Mononuclear Cells in Steroid-free Kidney Transplant Recipients.
timeFrame: Pre-transplant, 6months & 12 months post-transplant
Secondary outcomes:
measure: Donor Specific Hypo-reactivity.
timeFrame: Pre-transplant, 6mo & 12mo post-transplant
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Northwestern Memorial Hospital
state: Illinois
Study officials:
affiliation: Northwestern University, Northwestern Memorial Hospital, Northwestern Medical Faculty Foundation
name: Lorenzo Gallon, MD
role: PRINCIPAL_INVESTIGATOR
References: