Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00183248
Status:
COMPLETED
Last Update Posted:
2012-10-02
First Post:
2005-09-11
Brief Title:
Using Donor Stem Cells and Alemtuzumab to Prevent Organ Rejection in Kidney Transplant Patients
Sponsor:
University of Miami
Organization:
University of Miami
Study Overview
Official Title:
Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance ITN022ST
Status:
COMPLETED
Status Verified Date:
2012-09
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:
Alemtuzumab is a man-made antibody used to treat certain blood disorders This study will evaluate treatment of kidney transplant recipients with alemtuzumab and other immune system suppressing medications with or without infusions of bone marrow stem cells from the kidney donor The purpose of this study is to find out which strategy is more effective in preventing organ rejection and maintaining patient health
Detailed Description:
Organ transplantation is a common procedure in hospitals but organ rejection and serious side effects are potential problems for the patient Mycophenolate mofetil sirolimus and tacrolimus are drugs used to decrease immune system activity in people who have received organ transplants so that the new organ will not be rejected Alemtuzumab is a monoclonal antibody that binds to and depletes excess T cells in the bone marrow of leukemia patients In this study alemtuzumab will be used to destroy the recipients white blood cells WBCs at the time of transplantation It is hoped that WBCs produced after alemtuzumab administration will recognize the transplanted liver as self and will not attack the new kidney
To further assist the immune system in accepting the donor kidney some patients in this study will also receive two infusions of bone marrow stem cells from the kidney donor Bone marrow stem cells are adult blood cells from which other specialized blood cells such as T cells develop Treatment with these cells is believed to create a state of chimerism in the body where the immune cells of both the donor and recipient can coexist and tolerate the presence of a donor organ This study will evaluate the safety and effectiveness of an antirejection regimen including alemtuzumab and other immunosuppressive medications and donor bone marrow stem cell infusions in patients undergoing kidney transplantation
This study will last 3 years Participants will be randomly assigned to receive either the full immunosuppressive therapy and donor bone marrow stem cell infusions Group 1 or immunosuppressive therapy alone Group 2 Patients will undergo kidney transplantation at the start of the study on Day 0 Patients will receive inpatient infusions of alemtuzumab on Days 0 and 4 Starting on Day 0 patients will begin taking mycophenolate mofetil starting on Day 1 patients will also begin taking tacrolimus On Day 5 patients in Group 1 will receive their first of 2 infusions of purified stem cells taken from the kidney donors bone marrow their second infusion of stem cells will occur sometime between Months 4 and 6 post-transplant
Beginning between Months 4 and 6 post-transplant all participants will begin receiving low-dose maintenance immunosuppressive therapy with sirolimus as is typical for post-transplant antirejection therapy One year post-transplant patients will be evaluated for the potential to withdraw some or all of this maintenance immunotherapy Participants will be monitored for 3 years post-transplant Urine collection will occur at Week 1 and Months 1 3 6 and 9 At Months 12 24 and 30 participants will undergo kidney biopsies Blood collection will occur at regular intervals for laboratory tests to evaluate the immune systems response to the transplanted kidney
To further assist the immune system in accepting the donor kidney some patients in this study will also receive two infusions of bone marrow stem cells from the kidney donor Bone marrow stem cells are adult blood cells from which other specialized blood cells such as T cells develop Treatment with these cells is believed to create a state of chimerism in the body where the immune cells of both the donor and recipient can coexist and tolerate the presence of a donor organ This study will evaluate the safety and effectiveness of an antirejection regimen including alemtuzumab and other immunosuppressive medications and donor bone marrow stem cell infusions in patients undergoing kidney transplantation
This study will last 3 years Participants will be randomly assigned to receive either the full immunosuppressive therapy and donor bone marrow stem cell infusions Group 1 or immunosuppressive therapy alone Group 2 Patients will undergo kidney transplantation at the start of the study on Day 0 Patients will receive inpatient infusions of alemtuzumab on Days 0 and 4 Starting on Day 0 patients will begin taking mycophenolate mofetil starting on Day 1 patients will also begin taking tacrolimus On Day 5 patients in Group 1 will receive their first of 2 infusions of purified stem cells taken from the kidney donors bone marrow their second infusion of stem cells will occur sometime between Months 4 and 6 post-transplant
Beginning between Months 4 and 6 post-transplant all participants will begin receiving low-dose maintenance immunosuppressive therapy with sirolimus as is typical for post-transplant antirejection therapy One year post-transplant patients will be evaluated for the potential to withdraw some or all of this maintenance immunotherapy Participants will be monitored for 3 years post-transplant Urine collection will occur at Week 1 and Months 1 3 6 and 9 At Months 12 24 and 30 participants will undergo kidney biopsies Blood collection will occur at regular intervals for laboratory tests to evaluate the immune systems response to the transplanted kidney
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