Liver Transplantation, Liver Transplant Recipients
Conditions
Keywords
proteogenomic biomarker panels
Brief summary
The main focus of this study is to develop blood and/or urine tests that will help to detect early signs of rejection in people who have had a liver transplant. Researchers will examine blood, urine, and tissue samples and try to identify markers for certain conditions such as rejection, response to therapy, and scarring of the liver. Additionally, researchers would like to identify biomarkers that can detect damage to the native kidneys before blood levels of creatinine rises. By studying gene expression, researchers hope to be able to diagnose these conditions earlier and improve liver survival.
Interventions
None listed
Sponsors
Clinical Trials in Organ Transplantation
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects undergoing primary deceased-donor or living donor liver transplantation; * Subject must be able to understand and provide informed consent.
Exclusion criteria
* Need for combined organ transplantation; * Previous solid organ and/or islet cell transplantation; * Infection with HIV; * Allergy to iodine; * Inability or unwillingness of a participant to comply with study protocol; * Any condition that, in the opinion of the investigator, would interfere with the participant's ability to comply with study requirements.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute Rejection | 3 months after liver transplant | The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Recurrent Hepatitis-C Virus (HCV-R) | Baseline (Visit 1) to Month 24 (Visit 12) | Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R |
| Chronic Kidney Disease(CKD) | Baseline (Visit 1) to Month 24 (Visit 12) | Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD |
| Incidence of death, graft loss, and need for liver retransplantation | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| Incidence of opportunistic infections, malignancy, and cardiovascular complications | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| mRNA expression profiles of peripheral blood (AR, HCV-R, CKD) | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| Severity of acute rejection | Baseline (Visit 1) to Month 24 (Visit 12): | Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR |
| Protein expression profiles of plasma ( AR, HCV-R, CKD) | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| Protein expression profiles of urine (CKD) | Baseline (Visit 1) to Month 24 (visit 12) | — |
| microRNA Profiling Plasma & Cells | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| Multiparameter Flow Cytometry - Viral Pathogens | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| Viral Monitoring - EBV & CMV | Baseline (Visit 1) to Month 24 (Visit 12) | — |
| mRNA expression profiles of liver biopsies (AR, HCV-R) | Baseline (Visit 1) to Month 24 (Visit 12) | — |
Countries
United States
Outcome results
None listed