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| Sponsor: | National Institute of Allergy and Infectious Diseases (NIAID) |
|---|---|
| Collaborator: |
Immune Tolerance Network |
| Information provided by: | National Institute of Allergy and Infectious Diseases (NIAID) |
| ClinicalTrials.gov Identifier: | NCT00063817 |
Purpose
This study will examine the safety and effectiveness of a combination kidney and bone marrow transplant from a relative with the same (or nearly the same) blood cell type as the transplant recipient. An investigational medication will be given prior to and after the transplant to help protect the transplanted kidney from attack by the body's immune system.
| Condition | Intervention | Phase |
|---|---|---|
|
Kidney Failure Bone Marrow Transplantation Kidney Transplantation Kidney Failure, Chronic |
Drug: MEDI-507 Procedure: Combined kidney and bone marrow transplant Drug: Cyclosporine A Drug: Rituximab Drug: Corticosteroids |
Phase I |
| Study Type: | Interventional |
| Study Design: | Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study |
| Official Title: | Renal Allograft Tolerance Through Mixed Chimerism |
| Enrollment: | 5 |
| Study Start Date: | June 2003 |
| Estimated Study Completion Date: | July 2009 |
| Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
1: Experimental
Conditioning regimen consisting of cyclosporine A, rituximab, a short course of corticosteroids, and MEDI-507, followed by bone marrow and kidney transplantation occurring at the same time
|
Drug: MEDI-507
T-cell depleting antibody
Procedure: Combined kidney and bone marrow transplant
kidney and bone marrow transplant from same donor
Drug: Cyclosporine A
Immunosuppressant
Drug: Rituximab
B-cell suppressor
Drug: Corticosteroids
Immunosuppressant
|
Of the two currently available treatments for kidney failure, long-term dialysis and kidney transplantation, only kidney transplantation provides a potential cure. After a kidney transplant, the body's immune system recognizes the kidney as foreign and tries to attack and destroy it in a process called rejection. To avoid rejection, patients must take medications called immunosuppressants or anti-rejection drugs. It is believed that by transplanting bone marrow at the same time as a solid organ such as a kidney, a state of "mixed chimerism" (a mixing of the donor and recipient's immune system) can be achieved. Mixed chimerism may prevent rejection without the need for anti-rejection drugs.
Patients in this study will receive a simultaneous bone marrow and kidney transplant from the same living related donor in an attempt to establish mixed chimerism. Prior to transplantation, patients will undergo a "conditioning regimen" involving cyclophosphamide chemotherapy, radiation to the thymus gland, and four immunosuppressive medications: cyclosporine A, a man-made antibody known as rituximab to suppress B cells, a short course of steroids, and a T-cell depleting antibody known as MEDI-507. MEDI-507 is an investigational medication that has not been approved by the FDA. The primary goal of the study is to investigate the safety of the conditioning regimen and its ability to promote mixed chimerism so that the transplanted kidney is not destroyed. The study will also determine whether patients with mixed chimerism can eventually be safely removed from long-term immunosuppressive therapy following transplantation.
Patients will be assessed before and after transplantation and will be actively followed for 24 months. Patients will be monitored for graft rejection and medication toxicity. After Month 24, the study will continue with an additional 36 months of medical record-based surveillance.
Eligibility| Ages Eligible for Study: | 18 Years to 55 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Massachusetts | |
| Massachusetts General Hospital | |
| Boston, Massachusetts, United States, 02114 | |
| Principal Investigator: | David H. Sachs, MD | Department of Medicine, Massachusetts General Hospital |
| Principal Investigator: | A. Benedict Cosimi, MD | Department of Medicine, Massachusetts General Hospital |
More Information
| Responsible Party: | DAIT/NIAID ( Associate Director, Clinical Research Program ) |
| Study ID Numbers: | DAIT ITN010ST, DAIT NKD03 |
| Study First Received: | July 7, 2003 |
| Last Updated: | May 13, 2009 |
| ClinicalTrials.gov Identifier: | NCT00063817 History of Changes |
| Health Authority: | United States: Food and Drug Administration; United States: Institutional Review Board |
|
Renal Disease End-stage renal disease Renal Transplant Bone Marrow Transplant |
Tolerance, Chimerism Immune Tolerance ESRD |
|
Anti-Infective Agents Renal Insufficiency Cyclosporine Immunologic Factors Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Rituximab Physiological Effects of Drugs Kidney Failure, Chronic Enzyme Inhibitors Cyclosporins |
Immunosuppressive Agents Pharmacologic Actions Urologic Diseases Renal Insufficiency, Chronic Therapeutic Uses Antifungal Agents Kidney Diseases Antirheumatic Agents Dermatologic Agents Kidney Failure |
