Kidney Transplantation Clinical Trial
Official title:
Induction of Donor Specific Immunologic Hyporesponsiveness With Thymoglobulin, Sirolimus and Donor Bone Marrow Infusion
Patients with renal failure need chronic dialysis or a kidney transplant to survive. Most
kidney transplant patients must take medicines indefinitely to prevent their immune systems
from rejecting the kidney. Long-term exposure to these anti-rejection medicines can damage
the transplanted kidney.
The purpose of this study is to determine whether giving patients cells from the donor's bone
marrow will reduce or eliminate the need for long-term use of these anti-rejection drugs. In
addition to the donor's bone marrow cells, patients will receive the drugs thymoglobulin and
sirolimus.
A total of 20 patients will participate in this five-year study.
This protocol will evaluate the combination of Thymoglobulin (Sangstat), sirolimus and donor
bone marrow infusion for its ability to induce a state of donor specific hematopoietic
chimerism and immune hyporesponsiveness within the context of renal transplantation.
Thymoglobulin (Sangstat), a FDA-approved polyclonal rabbit-IgG antithymocyte preparation,
will be given for up to ten days at the time of transplantation to effect lymphocyte
depletion. This will be combined with sirolimus (rapamycin, Wyeth-Ayerst), an oral
immunosuppressant agent recently approved by the FDA. Sirolimus allows for antigen specific T
cell activation but prevents T cell clonal expansion by interrupting IL-2 receptor beta-chain
signal transduction. Donor bone marrow will be administered seven days following transplant.
Patients demonstrating six months of rejection free graft survival will have their sirolimus
withdrawn over three months beginning at the sixth month anniversary of the transplant.
Twenty people will be evaluated in this pilot protocol. Approximately ten will receive living
donor kidney allografts and the remaining patients will receive cadaveric kidney allografts.
Patients will be treated with Thymoglobulin beginning prior to graft implantation and
continuing for approximately ten days. Glucocorticosteroids will be given during the first
Thymoglobulin treatment to limit monocyte activation and prevent the cytokine release
syndrome associated with the initial administration of this antibody preparation. Patients
will be given sirolimus orally beginning the day after transplantation and continuously
thereafter. Donor bone marrow will be administered seven days following transplantation.
Patients will then be monitored for evidence of allograft rejection using standard functional
parameters and protocol allograft biopsies. In addition, patients will be followed for
specific desired effects, including a transient state of donor hematopoietic mixed
microchimerism and allospecific AICD. Both of these are expected to promote the development
of allospecific graft tolerance. This will be accomplished by assaying peripheral blood and
allograft biopsies for apoptosis and the peripheral blood for evidence of alloreactive T cell
clone depletion and donor chimerism.
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