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

NCT02736227 | Completed Results

• 1 other identifier: STU00201794
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Liver Transplantation

Keywords

liver transplantation; immunosuppression; everolimus; tacrolimus; kidney function; liver function; biomarkers

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Tacrolimus Withdrawal and Everolimus Monotherapy

EXPERIMENTAL

Tacrolimus will be tapered while continual use of everolimus.

Drug: Tacrolimus Withdrawal and Everolimus Monotherapy

Interventions

Tacrolimus Withdrawal and Everolimus Monotherapy DRUG

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.

Tacrolimus Withdrawal and Everolimus Monotherapy

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Northwestern University: lead
• Novartis Pharmaceuticals: collaborator

Study Sites (1)

Northwestern University Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

Location

Results Point of Contact

• Title: Josh Levitsky
• Organization: Northwestern University

j-levitsky@northwestern.edu

312-695-4413

Study Officials

• Josh Levitsky, MD, MS

  Northwestern University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor in Medicine-Gastroenterology and Hepatology and Surgery-Organ Transplantation

Study Record Dates

• First Submitted: March 24, 2016
• First Posted: April 13, 2016
• Study Start: March 1, 2016
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: October 7, 2022
• Results First Posted: October 7, 2022

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)