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

Not Applicable

Completed

• Conditions: Liver Transplantation
• Interventions: Drug: Tacrolimus Withdrawal and Everolimus Monotherapy

• Registration Number: NCT02736227
• Lead Sponsor: Northwestern University

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-03
• Study First Submitted: 2016-03-24
• Study First Submitted QC: 2016-04-07
• Study First Posted: 2016-04-13
• Primary Completion: 2021-03
• Study Completion: 2021-03
• Results First Submitted: 2022-03-03
• Status Verified: 2022-10
• Results First Submitted QC: 2022-10-04
• Last Update Submitted: 2022-10-04
• Results First Posted: 2022-10-07
• Last Update Posted: 2022-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

Inclusion Criteria

• Adult LT candidates ≥ 18 years of age
• Listed for or recent (within 1 month) recipient of deceased or living donor liver transplantation

Read More

Exclusion Criteria

• Combined or previous organ transplantation
• Human immunodeficiency virus (HIV) infection
• Inability to provide informed consent or comply with the protocol.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Tacrolimus Withdrawal and Everolimus Monotherapy	Tacrolimus Withdrawal and Everolimus Monotherapy	Tacrolimus will be tapered while continual use of everolimus.

Primary Outcome Measures

Name	Time	Method
Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection	Six months post transplantation	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)

Trial Locations

Locations (1)

Northwestern University Comprehensive Transplant Center; 🇺🇸 Chicago, Illinois, United States