Mycophenolic Acid Monotherapy in Recipients of HLA-identical Living-Related Transplantation
The objective of the study is to safely move HLA-identical renal transplant recipients from
2 immunosuppressive drugs (calcineurin inhibitor and mycophenolic acid) to mycophenolic acid
monotherapy. Safety will be assessed by monitoring renal function in subjects in the
withdrawal group compared to those who remain on the standard 2-drug immunosuppression
protocol. Results of immunological monitors such as DTH regulation in response to donor
minor antigens and development of anti-donor antibodies will be correlated with successful
withdrawal.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Incidence of kidney allograft rejection and graft loss
36 months
Yes
William Burlingham, PhD
Principal Investigator
University of Wisconsin, Madison
United States: Institutional Review Board
H-2005-0357
NCT01053221
March 2006
June 2013
Name | Location |
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University of Wisconsin | Madison,, Wisconsin 53792-5666 |