Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Northwestern University
- Enrollment
- 28
- Locations
- 1
- Primary Endpoint
- Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 89 Years (Adult, Older Adult)
- Sex
- 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.
Arms & Interventions
Tacrolimus Withdrawal and Everolimus Monotherapy
Tacrolimus will be tapered while continual use of everolimus.
Intervention: Tacrolimus Withdrawal and Everolimus Monotherapy (Drug)
Outcomes
Primary Outcomes
Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection
Time Frame: 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)
Secondary Outcomes
No secondary outcomes reported
Investigators
Josh Levitsky
Associate Professor in Medicine-Gastroenterology and Hepatology and Surgery-Organ Transplantation
Northwestern University