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| Name | Class |
|---|---|
| Clinical Trials in Organ Transplantation | NETWORK |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Liver Transplant Recipients |
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| Measure | Description | Time Frame |
|---|---|---|
| Acute Rejection | The primary endpoint is the incidence of biopsy proven AR at 3, 12 and 24 months after LT. | 3 months after liver transplant |
| Acute Rejection | 12 months after liver transplant | |
| Acute Rejection | 24 months after liver transplant |
| Measure | Description | Time Frame |
|---|---|---|
| Severity of acute rejection | Severity (initial grade, steroid-responsive vs. refractory by biopsy) and clinical/biochemical resolution following treatment of AR | Baseline (Visit 1) to Month 24 (Visit 12): |
| Recurrent Hepatitis-C Virus (HCV-R) |
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Inclusion Criteria:
Exclusion Criteria:
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Liver Transplant Recipients
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| Name | Affiliation | Role |
|---|---|---|
| Josh Levitsky, MD, MS | Northwestern University | Study Chair |
| Michael Abecassis, MD, MBA | Northwestern University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Phoenix | Arizona | 85054 | United States | ||
| Northwestern University, Feinberg School of Medicine |
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| Label | URL |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | View source |
| Clinical Trials in Organ Transplantation (CTOT) | View source |
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The plan is to share data in ImmPort, a long-term archive of clinical and mechanistic data from DAIT-funded grants and contracts that also provides data analysis tools that are available to researchers who register online and subsequently receive DAIT approval.
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whole blood, plasma, serum, urine supernatant, urine pellet and tissue
Incidence, severity (grade, stage), and treatment (requirement for, response rates) of HCV-R
| 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 | Baseline (Visit 1) to Month 24 (Visit 12) |
| 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) |
| mRNA expression profiles of liver biopsies (AR, HCV-R) | Baseline (Visit 1) to Month 24 (Visit 12) |
| 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) |
| Chicago |
| Illinois |
| 60611 |
| United States |
| Mount Sinai School of Medicine | New York | New York | 10029 | United States |
| Cleveland Clinic Foundation | Cleveland | Ohio | 44295 | United States |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | United States |
| Baylor University Medical Center | Dallas | Texas | 75246 | United States |