Multiple new immunosuppressive drugs are becoming available for prevention
of rejection in renal transplant recipients. Determining which of these
agents provides the best immunosuppressive protocol will require large
number of patients. An individual center will be unable to generate such
information. Multi-center studies such as that proposed will provide
evaluation of these agents at a much more rapid pace and will thus permit
the rapid dissemination of this new technology. We propose that the
cooperative trial initiate randomized study of FK506 versus cyclosporine in
a sequential therapy protocol. Cadaver transplant recipients will receive
prednisone and azathioprine at the time of surgery with antilymphocyte
globulin (ALG) started on the first post operative day. Patients will be
stratified for delayed graft function (DGF), diabetes, transplant number
(primary or retransplant), and for retransplants whether the first graft
was lost at < vs > 1 year, and will be randomized to receive either
cyclosporine or FK506 beginning on the 5th post operative day. We will
assess patient and graft survival, persistence of DGF, serum creatinines at
1 week, 2 week, 1 month and monthly thereafter, incidence of complications,
drug side effects, infections, rejection episodes, and malignancies. We
propose that evaluation of this agent be followed by evaluation of
Rapamycin, Deoxyspergualin, Mizoribine, and Succinylacetone as either
FK506/cyclosporine substitutes or as azathioprine substitutes. In
addition, the new monoclonal antibodies could be utilized in a randomized
arm versus ALG. However, each of these studies would compare a new agent
or combination of agents against best known therapy.
National Institute of Allergy and Infectious Diseases
CFDA Code
DUNS Number
555917996
UEI
KABJZBBJ4B54
Project Start Date
01-September-1991
Project End Date
31-August-1996
Budget Start Date
01-September-1994
Budget End Date
31-August-1995
Project Funding Information for 1994
Total Funding
$378,747
Direct Costs
$353,231
Indirect Costs
$126,554
Year
Funding IC
FY Total Cost by IC
1994
National Institute of Allergy and Infectious Diseases
$378,747
Year
Funding IC
FY Total Cost by IC
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