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Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant Clinical Trials Data presented on Clinical Trials Search is not meant to be a substitute for qualified health advice, visits or treatment with a real mD. We are not doctors. Always consult your doctor about Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant conditions. Clinical Trials Search.org is a site devoted to listing clinical research studies in human subjects. Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant Clinical research trials and Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant healthcare trials happen in many of places across the United States. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally assess the effectivity of new drugs. The purpose of the studies / projects is to solve particular human medical questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to discover cures for all varieties of conditions, such as Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant. Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant Clinical Trials and other clinical trials allow volunteers to have health treatment alternatives before they are available to the masses. Some times the human subjects obtain treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant clinical trial. Test subjects oftentimes receive the most effective healthcare possible for their Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant condition. Dangers are a reality, however, and may include extra or frequent physician visits, healthcare dangers (possibly life-jeopardising), and/or the treatment being uneffective. Trials are federally governed with rigorous guidelines to protect clinical trials patients.
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Home > "R" Clinical Trials Conditions > Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant  Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
For Condition: Bone Marrow Transplantation,Kidney Transplantation,Kidney Failure, Chronic,Kidney Failure
Status: Recruiting
Sponsor(s): National Institute of Allergy and Infectious Diseases (NIAID) , Immune Tolerance Network
Synopsis: 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.
Details: 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 two immunosuppressive medications: cyclosporine A 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:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
Minimum Age/Maximum Age: 18 Years/55 Years
Genders: Both
Protocol Entry Criteria: Inclusion Criteria - End-stage renal disease (ESRD) without prior sensitization (defined as Panel Reactive Antibody [PRA] > 20%) within the 6 months prior to study entry - Undergoing a first or second transplant - Receiving a transplant from a living related donor who is ABO (blood type) compatible and haploidentical (3,4, or 5 antigen match by serologic typing) - Negative donor lymphocyte cross-match - Seronegative for HIV-1, hepatitis B surface antigen (HbsAg), and hepatitis C virus - Cardiac ejection fraction > 40% - Forced expiratory volume (FEV1) > 50% - Liver function tests, bilirubin, and coagulation studies < 2 X normal - White blood cells < 2000/mm3 - Platelets < 100,000/mm3 Exclusion Criteria - History of cancer - Prior dose-limiting radiation therapy - Pregnant, breastfeeding, or planning pregnancy within the time frame of the study - Enrolled in another investigational drug study within 30 days prior to study entry
Total Enrollment: 10
Location and Contact Information:
Overall Study Official:
BenedictCosimi, Principal Investigator, Massachusetts General Hospital/ Department of Medicine
Massachusetts General Hospital *Recruiting*
Boston, Massachusetts, 02114
United States
Recruiting Nina Tolkoff-Rubin 617-726-3706
Additional Information:
Study ID Numbers: NKD03; DAIT NKD03
Study Start Date: June 2003
Record last reviewed: April 2004
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00063817
Other Kidney Failure Studies:
1. T-Cell Depletion in Unrelated Donor Marrow Transplantation
2. Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
3. Sibling Donor Cord Blood Banking and Transplantation
4. Valacyclovir in Immunocompromised Children
5. National Marrow Donor Program (NMDP)
Related Studies:
Other Kidney Failure Clinical Trials
Other Massachusetts Clinical Trials
Other Boston Clinical Trials
Reducing the Risk of Transplant Rejection: Simultaneous Kidney and Bone Marrow Transplant
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