Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab
| Status: | Terminated |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 65 |
| Updated: | 10/15/2017 |
| Start Date: | February 2006 |
| End Date: | April 2009 |
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
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.
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.
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.
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Northwestern Memorial Hospital Northwestern Memorial is an academic medical center hospital where the patient comes...
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