N/A
Completed N=28
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
Source: ClinicalTrials.gov NCT02736227 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Oct 2022
Primary outcomePrimary: Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection — 10; 5 percentage of CD4 positive cell
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Amount of Treg Cells Observed in Peripheral Blood in Patients With and Without Rejection |
10; 5 | — |
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.
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. Informational only — not medical advice.