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

NCT ID: NCT02736227

Last Updated: 2022-10-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 28 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-03-31
• Study Completion Date: 2021-03-31

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tacrolimus Withdrawal and Everolimus Monotherapy

Tacrolimus will be tapered while continual use of everolimus.

Group Type: EXPERIMENTAL

Tacrolimus Withdrawal and Everolimus Monotherapy

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: collaborator

Northwestern University

OTHER

Sponsor Role: lead

Responsible Party

Josh Levitsky

Associate Professor in Medicine-Gastroenterology and Hepatology and Surgery-Organ Transplantation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Josh Levitsky, MD, MS

Role: PRINCIPAL_INVESTIGATOR

Northwestern University

Locations

Northwestern University Comprehensive Transplant Center

Chicago, Illinois, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

STU00201794

Identifier Type: -

Identifier Source: org_study_id