N/A N=28 Treatment

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

Liver Transplantation

Bottom Line

View on ClinicalTrials.gov: NCT02736227 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Oct 2022

Primary outcome: Primary: Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection — 10; 5 percentage of CD4 positive cell

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: Tacrolimus Withdrawal and Everolimus Monotherapy (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Northwestern University
Primary completion: Mar 2021

Outcome Measures

Outcome	Result	p-value
PRIMARY Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection	10; 5	—

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.

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.

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02736227). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.