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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02736227
Recruitment Status : Recruiting
First Posted : April 13, 2016
Last Update Posted : April 16, 2019
Novartis Pharmaceuticals
Information provided by (Responsible Party):
Josh Levitsky, 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.

Condition or disease Intervention/treatment Phase
Liver Transplantation Drug: Tacrolimus Withdrawal and Everolimus Monotherapy Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Study Start Date : March 2016
Estimated Primary Completion Date : March 2020
Estimated Study Completion Date : March 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Tacrolimus Withdrawal and Everolimus Monotherapy
Tacrolimus will be tapered while continual use of everolimus.
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.

Primary Outcome Measures :
  1. Amount of Treg cells and mRNA observed in peripheral blood prior to and during tacrolimus withdrawal plus everolimus treatment. [ Time Frame: Six months post transplantation ]
    Sequential flow cytometry immunophenotyping and gene expression microassays

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02736227

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Contact: Josh Levitsky, MD, MS 312-695-4413
Contact: Patrice Al-Saden, RN 312-694-0232

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United States, Illinois
Northwestern University Comprehensive Transplant Center Recruiting
Chicago, Illinois, United States, 60611
Contact: Josh Levitsky, MD    312-695-4413      
Sponsors and Collaborators
Northwestern University
Novartis Pharmaceuticals
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Principal Investigator: Josh Levitsky, MD, MS Northwestern University

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Responsible Party: Josh Levitsky, Associate Professor in Medicine-Gastroenterology and Hepatology and Surgery-Organ Transplantation, Northwestern University Identifier: NCT02736227     History of Changes
Other Study ID Numbers: STU00201794
First Posted: April 13, 2016    Key Record Dates
Last Update Posted: April 16, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Josh Levitsky, Northwestern University:
liver transplantation
kidney function
liver function
Additional relevant MeSH terms:
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Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents