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Sponsors and Collaborators: |
National Institute of Allergy and Infectious Diseases (NIAID) Immune Tolerance Network |
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Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
ClinicalTrials.gov Identifier: | NCT00183248 |
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.
Condition | Intervention | Phase |
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Kidney Transplantation Kidney Disease Kidney Failure |
Drug: Alemtuzumab Drug: Mycophenolate mofetil Drug: Sirolimus Drug: Tacrolimus Procedure: Donor bone marrow stem cell infusion Procedure: Kidney transplant |
Phase I Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Single Blind (Subject), Active Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | Pilot Study Using Donor Stem Cells and Campath-1H to Induce Renal Transplant Tolerance |
Enrollment: | 9 |
Study Start Date: | September 2004 |
Estimated Study Completion Date: | May 2010 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Experimental
Kidney transplantation, followed by immunotherapy given along with kidney donor bone marrow stem cell infusions
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Drug: Alemtuzumab
Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4
Drug: Mycophenolate mofetil
Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study
Drug: Sirolimus
Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study
Drug: Tacrolimus
Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study
Procedure: Donor bone marrow stem cell infusion
2 doses of kidney donor's bone marrow stem cells by IV infusion on Day 5 and sometime between Months 4 and 6
Procedure: Kidney transplant
Occurs at study entry
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2: Active Comparator
Kidney transplantation, followed by immunotherapy
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Drug: Alemtuzumab
Immunosuppressant; 2 doses of drug by intravenous (IV) infusion on Days 0 and 4
Drug: Mycophenolate mofetil
Immunosuppressant; oral daily dose starting Day 0 until withdrawal or end of the study
Drug: Sirolimus
Immunosuppressant; oral daily dose starting between Months 4 and 6 post-transplant until withdrawal or end of the study
Drug: Tacrolimus
Immunosuppressant; daily dose starting Day 1 until withdrawal or end of the study
Procedure: Kidney transplant
Occurs at study entry
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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 recipient's 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 donor's 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 system's response to the transplanted kidney.
Ages Eligible for Study: | 18 Years to 65 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Florida | |
University of Miami | |
Miami, Florida, United States, 33136 |
Principal Investigator: | George W. Burke, III, MD | University of Miami |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN022ST |
Study First Received: | September 11, 2005 |
Last Updated: | September 26, 2008 |
ClinicalTrials.gov Identifier: | NCT00183248 |
Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
kidney kidney transplant kidney transplantation transplant transplantation renal |
renal transplant renal transplantation kidney disease chronic renal failure kidney failure |
Sirolimus Renal Insufficiency Urologic Diseases Alemtuzumab |
Mycophenolate mofetil Tacrolimus Kidney Diseases Kidney Failure |
Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Immunosuppressive Agents Pharmacologic Actions |