Sirolimus and Thymoglobulin to Prevent Kidney Transplant Rejection
Status:
Completed
Trial end date:
2007-12-01
Target enrollment:
Participant gender:
Summary
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...
Phase:
Phase 2
Details
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)