Ignite Creation Date:
2024-05-05 @ 10:54 PM
Last Modification Date:
2024-10-26 @ 10:25 AM
Study NCT ID:
NCT01213329
Status:
TERMINATED
Last Update Posted:
2019-04-10
First Post:
2010-09-30
Brief Title:
Immunophenotyping of Peripheral T Cells After T Cell Depletion With Alemtuzumab
Sponsor:
Northwestern University
Organization:
Northwestern University
Study Overview
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
Status:
TERMINATED
Status Verified Date:
2019-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 ones 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 ones 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None