Kidney Transplantation Clinical Trial
Official title:
A Multicenter, Open-Label, Study to Determine the Safety of BG9588 (Anti-CD40L Antibody) Therapy Compared to Standard Treatment in Renal Allograft Transplantation
The most common problem following a kidney transplant is the development of acute or chronic
rejection. Rejection is the immunologic reaction in which the body refuses to accept the
transplanted organ. The body's immune system will make destructive antibodies that will
attempt to attack the transplanted organ.
In order to prevent organ rejection, all patients receiving an allograft (a graft
transplanted between genetically non-identical individuals of the same species) must take
anti-rejection therapy. These medications function by lowering the body's natural immune
system. Often these medications are associated with significant side effects ranging from
infections to cancer.
This study is designed to test whether the drug presently known as BG9588 (Antova TM) can
reduce the incidence of organ rejection following kidney transplants in humans. More
specifically, the study will attempt to assess the safety of BG9588 when given alone or when
given in combination with other anti-rejection therapies. Safety will be measured by the
amount of acute or chronic rejections, and immunological graft losses.
Subjects for the study will be made up of non-human primates (monkeys) and humans. Up to 5
subjects in each of the groups receiving kidney transplants will be placed on a 12 month
course of BG9588 with or without additional anti-rejection drugs. BG9588 will be given
intravenously (injected through a vein) prior to the transplant and then in a decreased dose
with a decreased frequency over the year. Following the 12 months of therapy subjects may be
eligible for additional monthly therapy.
The long-term follow up will occur through 30 months after the last dose of BG9588. Subjects
will undergo periodic tests and evaluations throughout the course of the study. These tests
will assess the body's immune system and detect the presence of rejection.
This protocol is an open label, non-randomized study designed to test whether treatment with
BG9588, a humanized monoclonal antibody specific for CD154, can induce a state of allograft
tolerance following renal allotransplantation in humans. This study is designed to primarily
assess the safety and efficacy of BG9588 when given alone or in combination with steroids
and mycophenolate to prevent renal allograft rejection without the use of calcineurin
inhibitors or other chronic anti-rejection therapies. Efficacy parameters will include the
incidence of acute and chronic rejection episodes, and immunological graft loss. Additional
evaluation will be performed to specifically assess the development of donor-specific immune
hyporesponsiveness resulting from the use of BG9588.
This study is based on extensive use of BG9588 in non-human primates and pilot evaluation in
humans. Up to five patients in each group receiving primary renal allografts will be treated
with a 12-month course of BG9588 with or without steroids and mycophenolate to prevent
allograft rejection. The recruitment will be performed first in the group with steroids and
mycophenolate. Subjects will receive BG9588 at a dose of 70 mg/kg (based on ideal body
weight at baseline) via a continuous 60 minute IV infusion within 24 hours pre-operatively
followed by a 30 mg/kg dose via a continuous 30 minute IV infusion on the following days:
within 24 hours post-transplantation, and on days 3, 10, 18, 28, then monthly through 12
months post-transplantation. The enrollment will be staggered such that early efficacy will
be demonstrated in 5 patients prior to completing enrollment. Following 12 months of
therapy, patients may be extended to receive additional monthly therapy.
Long-term follow up will occur through 30 months after the last dose of BG9588. Mechanistic
evaluations testing for allograft tolerance will be performed throughout the study including
evaluations for allospecific T cell deletion, allospecific T cell anergy, and alloantibody
production. The donor population for this study will include both living donors and
cadaveric donors. This is being done to address the theoretical concern that ischemic
reperfusion injury may negatively affect the efficacy of BG9588.
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Endpoint Classification: Safety/Efficacy Study, Primary Purpose: Treatment
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