Kidney Transplant Recipients Clinical Trial
Official title:
Immune Monitoring and Calcineurin Inhibitor (CNI) Withdrawal in Low Risk Recipients of Kidney Transplantation
The study will compare how well transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn. In addition, this research study will evaluate whether reducing immunosuppression can decrease some of these side effects while still preventing rejection of the kidney.
Kidney transplantation is a treatment option for people with kidney disease. However, there
is still much to learn about how to best care for the transplanted kidney and keep it
functioning for a long time. Transplant recipients take immunosuppression (anti-rejection)
drugs to prevent their body from rejecting the new kidney. These drugs are used to prevent
the immune system from attacking the transplanted kidney. All anti-rejection medications
have unwanted side effects. The purpose of this study is to evaluate the safety of slowly
removing tacrolimus, a CNI.
POST STUDY TERMINATION NOTE: Although the investigators were unable to assess the primary
study end point due to early study termination,this trial supports the conclusion that risks
associated with acute rejection and donor-specific antibodies outweigh any potential
benefits of tacrolimus withdrawal, even in this highly selected, low-risk cohort of living
donor recipients treated with antithymocyte globulin induction.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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