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

Liver Transplantation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02736227
• Other study ID #: STU00201794
• Status: Completed
• Phase: N/A
• Start date: March 2016
• Est. completion date: March 2021

Study information

• Verified date: October 2022
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: March 2021
• Est. primary completion date: March 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 89 Years

Eligibility

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.

Related Conditions & MeSH terms

• Liver Transplantation

Intervention

Drug:
• Tacrolimus Withdrawal and Everolimus Monotherapy
During the first month post-transplant, the subject receives everolimus (about 5-8 ng/mL) and tacrolimus with or without mycophenolic acid as part of standard of care procedures. At one month post-transplant, mycophenolic acid will be stopped and tacrolimus dosage will be reduced while continuing the dosage of everolimus. At three months post-transplant, tacrolimus dosage will be reduced by 50% of the daily dose each week. At four months post-transplant, tacrolimus will be discontinued.

Locations

Country	Name	City	State
United States	Northwestern University Comprehensive Transplant Center	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Northwestern University	Novartis Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection	flow cytometry immunophenotyping and gene expression microassays to assess amount of Treg cells and mRNA in peripheral blood in patients with and without rejection (after Tacc withdrwal)	Six months post transplantation