Kidney Failure Clinical Trial
Official title:
Sirolimus Monotherapy to Optimize Activation Induced Cell Death (AICD) in Renal Transplants Following Lymphocyte Depletion Induction With Thymoglobulin
Verified date | June 2010 |
Source | National Institutes of Health Clinical Center (CC) |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study will test the safety and effectiveness of two drugs, Sirolimus and Thymoglobulin,
for preventing rejection of transplanted kidneys. Standard anti-rejection therapy uses a
combination of drugs, such as cyclosporine, tacrolimus, azathioprine, steroids, and others,
that are taken daily for life. However, even with this daily therapy, more than half of
kidney recipients slowly reject their transplant within 10 years. Both Thymoglobulin, an
antibody, and Sirolimus, an anti-rejection drug, prevent rejection by lowering the response
of the immune system to the transplanted organ. Thymoglobulin is given in the pre- and
postoperative period, and Sirolimus is taken long term.
Patients who receive a kidney transplant at the National Institutes of Health Clinical Center
are eligible for this study. Candidates will be screened with a medical history, physical
examination, and blood and urine tests.
Participants will undergo a kidney transplant. Before the surgery, a central line
(intravenous catheter), through which blood and medicine can be given, is placed in the neck
or chest. Patients may also undergo leukapheresis, a procedure for collecting white blood
cells. The cells can be stored for transfusion later if white cell counts drop following
Thymoglobulin treatment. For this procedure, blood is drawn from a needle placed in the arm
and flows into a machine that separates the blood components by spinning. The white cells are
collected in a bag and the red cells and plasma are returned through a second needle in the
other arm.
Thymoglobulin will be given intravenously the day before the transplant and days 1 through 9
after the operation. Sirolimus will be taken by mouth, mixed with water or orange juice.
Sirolimus therapy starts the day of the transplant and continues for life.
Follow-up study visits will be scheduled weekly for the first month after the transplant,
then every 6 months for 1 year and then once a year for 4 years. Procedures during these
visits may include blood and urine tests, physical examination, and check of vital signs
(i.e., blood pressure, heart rate, breathing rate, temperature). Kidney biopsies (removal of
a small piece of tissue for examination under the microscope) will be done at 2 weeks, 1
month and 6 months after surgery and then yearly for 4 years to check for any damage to the
kidney. In addition, a local doctor will do routine laboratory tests 2 to 3 times a week for
the first 2 to 3 months aft...
Status | Completed |
Enrollment | 12 |
Est. completion date | December 2007 |
Est. primary completion date | December 2007 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
- INCLUSION CRITERIA: Candidates for a kidney transplant performed at the NIH Clinical Center. Willingness and legal ability to give informed consent. 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 Clinical 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 may not be taking prednisone, cyclosporine, tacrolimus, azathioprine, mycophenolate mofetil, anti-lymphocyte agents, cyclophosphamide, methotrexate, or other agents whose therapeutic effect is immunosuppressive. 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). Any known immunodeficiency syndrome. Any history of cardiac insufficiency, major vascular disease, symptomatic coronary artery disease. Systemic or pulmonary edema. Inability to be effectively dialyzed. Any condition that would likely increase the risk of protocol participation or confound the interpretation of the data. Any history of sensitization to rabbits or extensive exposure to rabbits. Inability or unwillingness to comply with protocol monitoring and therapy, including, among others, a history of noncompliance, circumstances where compliance with protocol requirements is not feasible due to living conditions, travel restrictions, access to urgent medical services, or access to anti-rejection drugs after the research protocol is completed. |
Country | Name | City | State |
---|---|---|---|
United States | National Institutes of Health Clinical Center, 9000 Rockville Pike | Bethesda | Maryland |
Lead Sponsor | Collaborator |
---|---|
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
United States,
Matas AJ, Gillingham KJ, Sutherland DE. Half-life and risk factors for kidney transplant outcome--importance of death with function. Transplantation. 1993 Apr;55(4):757-61. — View Citation
Morris PJ. Renal transplantation: a quarter century of achievement. Semin Nephrol. 1997 May;17(3):188-95. — View Citation
Swanson SJ, Hale DA, Mannon RB, Kleiner DE, Cendales LC, Chamberlain CE, Polly SM, Harlan DM, Kirk AD. Kidney transplantation with rabbit antithymocyte globulin induction and sirolimus monotherapy. Lancet. 2002 Nov 23;360(9346):1662-4. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Serum Creatinine Concentration | measures at 6 months after intervention | 6 months after intervention | |
Primary | Serum Creatinine Concentration | measures at 12 months after intervention | 12 months after intervention | |
Secondary | Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney) | measure 6 months after intervention | 6 month after intervention | |
Secondary | Glomerular Filtration Rate (Flow Rate of Filtered Fluid Through the Kidney) | measure at 12 months after intervention | 12 months after intervention |
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