NCT01213329

Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab

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

• Status: Terminated
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Northwestern University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Kidney Transplant

Interventions

Type	Name	Description
DRUG	Alemtuzumab	All kidney transplant recipients received one 30mg dose (IV push) of Alemtuzumab in operating room per Standard of Care.

Timeline

• Start date: 2006-02-01
• Primary completion: 2009-04-01
• Completion: 2009-04-01
• First posted: 2010-10-04
• Last updated: 2019-04-10
• Results posted: 2011-07-04

Locations

1 site across 1 country: United States