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.
Study Type
OBSERVATIONAL
Enrollment
202
Mayo Clinic
Phoenix, Arizona, United States
Northwestern University, Feinberg School of Medicine
Chicago, Illinois, United States
Mount Sinai School of Medicine
New York, New York, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Baylor University Medical Center
Dallas, Texas, United States
Acute Rejection
The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT.
Time frame: 3 months after liver transplant
Acute Rejection
Time frame: 12 months after liver transplant
Acute Rejection
Time frame: 24 months after liver transplant
Severity of acute rejection
Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR
Time frame: Baseline (Visit 1) to Month 24 (Visit 12):
Recurrent Hepatitis-C Virus (HCV-R)
Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Chronic Kidney Disease(CKD)
Incidence, severity (stage, need for renal replacement therapy or kidney transplantation), and response to treatment (CNI reduction/withdrawal ± MPA or mTOR) of CKD
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of death, graft loss, and need for liver retransplantation
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Incidence of opportunistic infections, malignancy, and cardiovascular complications
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
mRNA expression profiles of peripheral blood (AR, HCV-R, CKD)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
mRNA expression profiles of liver biopsies (AR, HCV-R)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of plasma ( AR, HCV-R, CKD)
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Protein expression profiles of urine (CKD)
Time frame: Baseline (Visit 1) to Month 24 (visit 12)
microRNA Profiling Plasma & Cells
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Multiparameter Flow Cytometry - Viral Pathogens
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
Viral Monitoring - EBV & CMV
Time frame: Baseline (Visit 1) to Month 24 (Visit 12)
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