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Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys Clinical Trials Facts presented on Clinical Trials Search isn't designed to be a substitute for proven healthcare advice, calls or treatment by using a genuine medical doctor. We aren't mDs. Always confer with your doctor on Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys conditions. Clinical Trials Search.org is a website devoted to listing clinical research studies in human subjects. Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys Clinical research trials and Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys healthcare trials occur in a lot of 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 does drugs. The role of the studies / undertakings is to solve specific human healthcare questions. Clinical trials are a popular way for doctors, government agencies, and private sector companies to find treatments for all kinds of conditions, including Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys. Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys Clinical Trials and other clinical trials allow for volunteers to access health treatment choices before they are available to the general public. Many times the test subjects get treatment for without cost, and sometimes they are compensated for their time. Occasionally there is a cost for a Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys clinical trial. Test subjects typically receive the most effective healthcare possible for their Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys condition. Risks are a reality, nonetheless, and could include extra or frequent dr. calls, health hazards (perhaps life-jeopardizing), and/or the treatment being ineffective. Trials are federally regulated with rigid guidelines to protect clinical trials subjects.
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Home > "E" Clinical Trials Conditions > Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys  Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
For Condition: Graft Rejection,Kidney Disease
Status: No longer recruiting
Sponsor(s): National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) ,
Synopsis: This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits the NFkB pathway thus preventing monocyte and macrophage activation. Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H prior to transplantation to insure that peripheral depletion is achieved at the time of graft reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third and fifth days after the transplant to deplete passenger donor leukocytes and residual recipient cells that mobilize in response to the allograft. In addition, patients will be treated with DSG for 14 days beginning on the day prior to surgery. This trial expands on pilot studies at the NIH of 15 patients in which Campath was given alone at the time of transplantation. In those studies, excellent peripheral depletion occurred after just one dose of Campath though central depletion required additional dosing. This allowed for greatly reduced immunosuppression to be used to prevent rejection, but to date, all patients have required some immunosuppressive medication. It is hoped that the addition of DSG will eliminate the need for long-term immunosuppression. Patients will be followed closely in the post transplant period. If patients experience rejection, they will be treated with methylprednisolone and have immunosuppression added using sirolimus as the predominant immunosuppressive agent. In the previous phase of this study without DSG, this maneuver has in all cases been successful in returning the allograft to normal function. In addition to evaluating graft function following transplantation, this protocol will also characterize and evaluate the function of the immune system and the composition of the T cell repertoire following the administration of Campath-1H and DSG, and during immune system recovery after transplantation.
Details: This protocol will test a humanized monoclonal antibody known as Campath-1H for its ability to induce a state of permanent allograft acceptance, or tolerance, when administered in combination with a brief course of the immunosuppressive drug deoxyspergualin (DSG) at the time of human renal allotransplantation. Campath-1H is specific for the common lymphocyte and monocyte antigen CD52. Its administration temporarily depletes mature lymphocytes and some monocytes without altering neutrophils or hematopoietic stem cells. Deoxyspergualin inhibits the NFkB pathway thus preventing monocyte and macrophage activation. Recipients of living or cadaveric donor kidneys will be treated with one dose of Campath-1H prior to transplantation to insure that peripheral depletion is achieved at the time of graft reperfusion. Three subsequent doses of Campath-1H will be administered on the first, third and fifth days after the transplant to deplete passenger donor leukocytes and residual recipient cells that mobilize in response to the allograft. In addition, patients will be treated with DSG for 14 days beginning on day 12 after surgery. This trial expands on pilot studies at the NIH of 17 patients in which Campath was given alone at the time of transplantation with and without DSG. In those studies, excellent peripheral depletion occurred after just one dose of Campath though central depletion required additional dosing. Lasting, rejection-free survival was not realized without the addition of some, albeit reduced, immunosuppression. This is thought to be due to residual post-operative monocytes that infiltrated the allograft. It is hoped that the administration of DSG will eliminate the need for long-term immunosuppression. Patients will be followed closely in the post transplant period. If patients experience rejection, they will be treated with methylprednisolone and have immunosuppression added using sirolimus as the predominant immunosuppressive agent. In the previous phase of this study without DSG, this maneuver has in all cases been successful in returning the allograft to normal function. In addition to evaluating graft function following transplantation, this protocol will also characterize and evaluate the function of the immune system and the composition of the T cell repertoire following the administration of Campath-1H and DSG, and during immune system recovery after transplantation.
Eligibility:
Study Type: Interventional, Treatment, Safety/Efficacy
Minimum Age/Maximum Age: /
Genders: Both
Protocol Entry Criteria: INCLUSION CRITERIA: Candidates for a kidney transplant performed at the Warren G. Magnuson Clinical Center. Willingness and legal ability to give informed consent, or permission from a legal guardian. Willingness to travel to the Clinical Center for protocol specific samples to be taken, or in some cases, the ability to send samples via overnight mail. Availability of donor tissue for testing. This could include splenic or peripheral blood lymphocytes from a cadaveric donor or a willing living donor enrolled on the Clinic Center Living Donor Protocol who consents to periodic phlebotomy for peripheral blood lymphocyte isolation. EXCLUSION CRITERIA: Immunosuppressive drug therapy at the time of or 2 months prior to enrollment. Specifically, candidates must not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, antilymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppresive. Any condition that precludes serial follow-up. Any active malignancy or any history of a hematogenous malignancy or lymphoma. Patients with primary, cutaneous basal cell or squamous cell cancers may be enrolled providing the lesions are appropriately treated prior to transplant. Significant coagulopathy or requirement for anticoagulation therapy that would contraindicate protocol allograft biopsies. Platelet count less than 100,000/mm(3). Hemoglobin less than 9.0 mg/dl. Patients may be on erythropoietin therapy, but will not be placed on therapy solely to facilitate research sample acquisition. Any known immunodeficiency syndrome. HLA identical status with a living donor. Any history of uncompensated cardiac insufficiency, major vascular disease, or symptomatic coronary artery disease. Systemic or pulmonary edema. Inability to be effectively dialyzed. Chronic hypotension (SBP less than 100 mmHg). Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data. CMV negative status receiving an organ from a known CMV positive donor. EBV negative status receiving an organ from a known EBV positive donor. Panel reactive antibody greater than 20% due to HLA antibodies.
Total Enrollment: 20
Location and Contact Information:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Bethesda, Maryland, 20892
United States
Additional Information:
Study ID Numbers: 000013; 00-DK-0013
Study Start Date: November 9, 1999
Record last reviewed: October 20, 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00001984
Other Graft Rejection Studies:
1. Study comparing the safety and efficacy of BMS-224818 to cyclosporine, in patients receiving a kidney transplant, when used in combination with CellCept, Simulect, and corticosteroids.
2. Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
3. Monitoring for Tolerance to Kidney or Combined Kidney-Pancreas Transplants
Related Studies:
Other Graft Rejection Clinical Trials
Other Maryland Clinical Trials
Other Bethesda Clinical Trials
Effectiveness of the Investigational Drug Campath-1H in Preventing Rejection of Transplanted Kidneys
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