Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation



Status:Recruiting
Healthy:No
Age Range:18 - 89
Updated:4/21/2016
Start Date:March 2016
End Date:March 2019
Contact:Josh Levitsky, MD, MS
Email:j-levitsky@northwestern.edu
Phone:312-695-4413

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Most patients who get a liver transplant must take immunosuppressants for the rest of their
lives. However, this has occurred at the expense of chronic CNI toxicity, e.g. chronic
kidney disease (CKD), metabolic complications, infections and malignancy. Everolimus (EVL)
is a drug that may stabilize or improve kidney function for patients with chronic kidney
disease (CKD) that has been caused by immunosuppressants. EVL is used for standard of care
treatment to prevent transplant liver rejection in combination with other
immunosuppressants, such as tacrolimus. The overall aim of this study is to examine a
combination of two different immunosuppressants and EVL to determine if patients may have
stabilized and/or improved kidney function without liver rejection. This study will look at
how safe it is to slowly withdraw one anti-rejection medication while continuing to take the
other medicine, and whether this can be done without liver rejection occurrence.


Inclusion Criteria:

- Adult LT candidates ≥ 18 years of age

- Listed for or recent (within 1 month) recipient of deceased or living donor liver
transplantation

Exclusion Criteria:

- Combined or previous organ transplantation

- Human immunodeficiency virus (HIV) infection

- Inability to provide informed consent or comply with the protocol.
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Chicago, Illinois 60611
Phone: 312-695-4413
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