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Clinical Trial Summary

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transplanted kidneys work and the response of people's immune systems as tacrolimus, a calcineurin inhibitor (CNI), is withdrawn.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.


Clinical Trial Description

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. ;


Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01517984
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Terminated
Phase Phase 2
Start date November 2010
Completion date May 2015

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