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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: | NCT00801632 |
In small initial studies, combined kidney and bone marrow transplants from the same donor have permitted some individuals to stop taking anti-rejection medicines without rejecting their transplant. This clinical trial will study this method in a greater number of people to determine if it is indeed effective and safe.
Condition | Intervention | Phase |
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Kidney Transplantation Kidney Failure, Chronic |
Procedure: Kidney Transplant Procedure: Bone marrow transplant Drug: MEDI-507 Drug: Cyclophosphamide Drug: Rituximab Drug: tacrolimus Drug: Corticosteroids Radiation: Radiation to the thymus gland |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Single Group Assignment, Efficacy Study |
Official Title: | Renal Allograft Tolerance Through Mixed Chimerism |
Estimated Enrollment: | 15 |
Study Start Date: | December 2008 |
Estimated Study Completion Date: | December 2015 |
Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Protocol: Experimental
Combined kidney and bone marrow transplant
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Procedure: Kidney Transplant
Surgical transplantation of donor kidney
Procedure: Bone marrow transplant
During kidney transplant, bone marrow cells donated by the same donor as the kidney are given through a plastic tube placed in a vein in the chest, underneath the collarbone
Drug: MEDI-507
0.1 mg/kg on day -2; 0.6 mg/kg on days -1,0,1
Drug: Cyclophosphamide
60 mg/kg infusion on days -5, -4
Drug: Rituximab
375 mg/m2 infusion on days -7, -2, 5, and 12
Drug: tacrolimus
0.05 mg/kg IV twice a day starting on day -1, adjusted to trough level of 10-15ng/ml, then tapered (if eligible) on days 1, 7, 14, 21, 28, 42, and 56
Drug: Corticosteroids
2 mg/kg prednisone on day 4, with an additional 500-mg pulse of methylprednisolone given on days 10, 11, and 12, and then tapered off by day 20
Radiation: Radiation to the thymus gland
700 cGy of thymic irradiation are administered in a single dose on day -1
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All patients receiving an organ or tissue transplant must take special medicines known as "immunosuppressive drugs" in order to prevent the immune system from rejecting the transplant. These drugs can be very effective, but they leave the patient at an increased risk of serious infections and certain types of cancer. New methods of preventing transplant rejection are needed.
Researchers have found that transplanting both bone marrow and a kidney from the same donor can create what is called "mixed chimerism." This means that the transplant recipient has a mixture of the donor and recipient's immune systems. It is believed that this mixture of immune cells can prevent rejection of the kidney. In a small prior study, performing a kidney transplant together with a bone marrow transplant from the same donor allowed 4 of 5 patients to stop taking immunosuppressive drugs altogether, without rejecting their transplant. This clinical trial will study more patients to confirm if the technique is safe and effective.
Patients eligible for this study must be candidates for a living kidney transplant, and have an eligible donor identified. The transplant recipient and donor must both consent to participate in this study. Transplant recipients enrolled in the study will receive both kidney and bone marrow transplants from the same living donor. Prior to the transplant procedure, the transplant recipient will undergo a "conditioning regimen" that makes room in their immune system for the recipient's immune (bone marrow) cells. This conditioning regimen is a combination of chemotherapy, radiation, immunosuppressive drugs and specialized medications called rituximab and MEDI-507. MEDI-507 is an investigational medication that has not been approved by the FDA. After the transplant procedure, transplant recipients will be prescribed steroids for several weeks and immunosuppressive drugs. After 2 months, the dose of the immunosuppressive drugs will slowly be decreased to zero in patients whose immune system and kidney function meet certain criteria.
Transplant recipients enrolled into the study will be hospitalized for 1 week prior to the transplant procedure. After the transplant, patients will remain in the hospital until the doctor feels they are well enough to go home. Recipients will receive approximately monthly checkups over a period of 2 years after transplant and may be asked attend checkups once per year for up to 3 additional years. Checkups will include physical exams, and blood and urine tests to assess immune system and kidney function. At four of these checkups, a kidney biopsy will be requested.
Transplant donors enrolled in the study will attend a screening visit, which will include a physical exam, blood tests and chest x-ray. Eligible donors will be admitted to the hospital for 3-5 days, where bone marrow will be collected prior to removal of the kidney. Transplant donors may be asked at a later date to donate additional blood samples for research purposes.
Ages Eligible for Study: | 18 Years to 60 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Sandy deBronkart, RN | (617) 726-2631 | sdebronkart@partners.org |
United States, Massachusetts | |
Massachusetts General Hospital | Recruiting |
Boston, Massachusetts, United States, 02114 | |
Contact: Sandy deBronkart, RN 617-726-2631 sdebronkart@partners.org | |
Principal Investigator: David H Sachs, MD | |
United States, New York | |
New York-Presbyterian/Weill Cornell Medical Center | Not yet recruiting |
New York, New York, United States | |
Principal Investigator: Manikkam Suthanthiran, MD | |
United States, Pennsylvania | |
University of Pennsylvania | Not yet recruiting |
Philadelphia, Pennsylvania, United States | |
Principal Investigator: Abraham Shaked, MD, PhD |
Principal Investigator: | David Sachs, MD | Massacusetts General Hospital |
Principal Investigator: | Ben Cosimi, MD | Massachusetts General Hospital |
Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
Study ID Numbers: | ITN036ST |
Study First Received: | December 2, 2008 |
Last Updated: | December 30, 2008 |
ClinicalTrials.gov Identifier: | NCT00801632 |
Health Authority: | United States: Institutional Review Board; United States: Food and Drug Administration |
kidney renal transplant transplantation kidney transplant rejection antirejection |
immunosuppression tolerance transplant tolerance immune tolerance mixed chimerism bone marrow |
Prednisone Renal Insufficiency Rituximab Methylprednisolone Kidney Failure, Chronic Methylprednisolone acetate Prednisolone acetate Cyclophosphamide |
Tacrolimus Urologic Diseases Renal Insufficiency, Chronic Prednisolone Kidney Diseases Kidney Failure Methylprednisolone Hemisuccinate |
Anti-Inflammatory Agents Antineoplastic Agents, Hormonal Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Hormones, Hormone Substitutes, and Hormone Antagonists Gastrointestinal Agents Antiemetics Hormones Glucocorticoids Protective Agents |
Neuroprotective Agents Immunosuppressive Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Myeloablative Agonists Peripheral Nervous System Agents Antineoplastic Agents, Alkylating Antirheumatic Agents Central Nervous System Agents Alkylating Agents |