Clinical trials: Liver Transplant Rejection
Liver Transplant
Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation
To determine whether long-term maintenance therapy with a single drug (Myfortic) applied using advanced immunologic monitoring tools in selected patients can lead to superior native kidney function at 2 years without resulting in…
- Trial name
- NCT01230502
- Testing
- Group 1 Donor Specific Regulation (DSR) +, Mycophenolic acid (MPA) monotherapy, data and sample collection
- Where
- United States
- Volunteers
- 11 people
- Sponsor
- University of Wisconsin, Madison
Liver Transplant Failure and Rejection
Parenteral Ascorbic Acid Repletion in TransplantatIon
A single-center, randomized, double-blinded placebo-controlled trial is proposed to investigate administration of supraphysiologic doses of ascorbic acid (vitamin C, AA) to patients undergoing liver transplantation.
- Trial name
- PARTI (NCT04756063)
- Testing
- Ascorbic acid
- Where
- United States
- Sponsor
- University of Wisconsin, Madison
Acute Graft Rejection
Diagnosis of Graft Pathology by TruGraf
The goal of this observational study is to to identify different causes of liver diseases or damage in liver transplant patients and develop a machine learning algorithm as a non-invasive tool leveraging gene expression and…
- Trial name
- NCT06557564
- Testing
- TruGraf liver gene expression
- Where
- Canada
- Volunteers
- 471 people
- Sponsor
- University Health Network, Toronto
Liver Transplant, Hepatitis C
Proteogenomic Monitoring and Assessment of Liver Transplant Recipients
This study is being done to test blood, urine and tissue samples to see if this can help decide if CKD (Chronic Kidney Disease), AR (Acute Rejection) and HCV (Hepatitis C Virus) can be identified in its early stages.
- Conditions
- Liver Transplant, Hepatitis C, Chronic Kidney Disease, Acute Rejection
- Trial name
- "Mini-Liver" (NCT01644903)
- Where
- United States
- Volunteers
- 1,000 people
- Sponsor
- Northwestern University
Immunosuppression After Liver Transplantation
Conversion Prograf® to Advagraf® at D7 Versus D90 After Liver Transplantation
The best period for the conversion from Prograf (tacrolimus administered twice daily) to Advagraf (once-daily prolonged-release tacrolimus) remains unknown.
- Trial name
- Conversion (NCT02105155)
- Testing
- Conversion at day 7 ± 3 Prograf® to Advagraf®, Conversion at day 90±5 Prograf® to Advagraf®
- Where
- France
- Volunteers
- 90 people
- Sponsor
- Assistance Publique - Hôpitaux de Paris
Kidney Transplant; Complications, Liver Transplant; Complications
MR-proADM as a Early Biomarker for DGF and AR in Kidney and Liver Transplantation
To define the sensibility and the specificity of increased levels of MR-proADM for early, non-invasive, diagnosis of AR and DGF after kidney and liver transplantation creating a predictive model for related complications after…
- Trial name
- DARE (NCT06130046)
- Testing
- MR-proADM dosage
- Where
- Italy
- Volunteers
- 300 people
- Sponsor
- University of Rome Tor Vergata
Liver Allograft, Liver Diseases
Everolimus bAsed caLcineurin inhibiTor frEe immunosuppRession oNe Year AfTer lIver transplantatiON (ALTERNATION)
The overall aim of this study is nephroprotection based on a calcineurin inhibitor (CNI)-free therapy beyond year one after orthotopic liver transplantation (OLT) in highly pre-selected patients with low rejection risk.
- Conditions
- Liver Allograft, Liver Diseases, Liver Transplantation
- Trial name
- ALTERNATION (NCT07739914)
- Testing
- Everolimus, Tacrolimus or Cyclosporine
- Where
- 16 sites in Germany
- Volunteers
- 150 people
- Sponsor
- Hannover Medical School
Heart Failure, Liver Fibrosis
Magnetic Resonance Elastography as a Method to Estimate Stiffness of Soft Tissues
Magnetic resonance elastography is a novel non-invasive MRI technique to obtain stiffness of soft tissues such as liver, heart, kidneys, etc.
- Conditions
- Heart Failure, Liver Fibrosis, Cardiac Transplant Rejection, Aortic Aneurysms
- Trial name
- MRE (NCT01757730)
- Where
- United States
- Volunteers
- 1,000 people, healthy volunteers welcome
- Sponsor
- Arunark Kolipaka
Immunosuppression, Kidney Transplant Rejection
The New LC-MS/MS Method for Determination of Unbound Tacrolimus in Plasma
Tacrolimus (TAC) is characterized by a narrow therapeutic window, as well as high inter- and intra-individual variability in pharmacokinetics. Both under- and overexposure may lead to severe adverse effects.
- Conditions
- Immunosuppression, Kidney Transplant Rejection, Kidney Transplant; Complications, Liver Transplant Rejection
- Trial name
- FreeTAC (NCT04657562)
- Testing
- Tacrolimus, Unbound tacrolimus measurement, CYP3A4 and CYP3A5 genotyping
- Where
- Poland
- Volunteers
- 380 people
- Sponsor
- National Science Centre, Poland
Liver Transplant Failure and Rejection, Children, Only
Histologic Evolution of Patients With Liver Transplantation
Certain pediatric liver transplant patients with immunosuppression levels in the therapeutic range and normal liver function tests present histological alterations (inflammation or fibrosis) in protocol biopsies.
- Trial name
- NCT06103097
- Testing
- No interventions done (obervational)
- Where
- Spain
- Volunteers
- 200 people
- Sponsor
- Hospital Vall d'Hebron
Rejection; Transplant, Liver
Transcriptomics as an Aid in the Histological Diagnosis of Acute Rejection After Liver Transplantation
The primary objective of this exploratory study is to identify genes associated with acute rejection in liver transplant patients.
- Trial name
- NCT06734013
- Testing
- Molecular diagnostic
- Where
- Italy
- Volunteers
- 40 people
- Sponsor
- IRCCS Azienda Ospedaliero-Universitaria di Bologna
Liver Transplant Rejection
Erythropoietin Therapy to Induce Regulatory T Cells in Liver Transplant Recipients
The hypothesis of this proof-of-concept study is that EPO increases the frequency, stability and/or function of Tregs in liver transplant recipients. We also hypothesize that EPO will have a greater effect in everolimus vs.
- Trial name
- NCT05325073
- Testing
- Erythropoietin
- Where
- United States
- Volunteers
- 9 people
- Sponsor
- Northwestern University
Covid19, Kidney Transplant; Complications
Multicenter CTS Pre-and Post-Transplantation Covid-19 Serum Studies
The Covid-19 Serum Study is a prospective case-control study in 1. kidney or liver transplanted patients being hospitalized due to an infection with Severe Acute Respiratory Syndrome Coronavirus Type 2 (SARS-CoV-2) after…
- Conditions
- Covid19, Kidney Transplant; Complications, Kidney Transplant Failure and Rejection, Liver Transplant; Complications
- Trial name
- NCT04694573
- Where
- Germany
- Volunteers
- 600 people
- Sponsor
- Heidelberg University
Liver Transplantation
Liver Spare the Nephron (STN) Study - A Study of CellCept (Mycophenolate Mofetil) and Sirolimus in Recipients of a Liver Transplant
This two-arm study will assess the efficacy and safety of a long-term calcineurin inhibitor-free maintenance regimen with CellCept and sirolimus in recipients of an orthotropic liver transplant.
- Trial name
- NCT00118742
- Testing
- mycophenolate mofetil [CellCept], Tacrolimus, Cyclosporine
- Where
- 46 sites in United States, Canada
- Volunteers
- 293 people
- Sponsor
- Hoffmann-La Roche
Prophylaxis Against Liver Transplant Rejection
Bioavailability and Practicability of Envarsus Versus Advagraf in Liver Transplant Recipients
Trial participants are randomised within 14 days after liver transplantation surgery in a 1:1 ratio to two alternative treatment arms containing either Envarsus® (test arm) or Advagraf® (comparator arm) as first-line calcineurin…
- Trial name
- NCT04720326
- Testing
- Tacrolimus Pill, Tacrolimus capsule
- Where
- 15 sites in Germany
- Volunteers
- 268 people
- Sponsor
- Edward Geissler
Heart Failure, Respiratory Failure
Donor Simvastatin Treatment in Organ Transplantation
The aim of the study is to investigate the effects of donor simvastatin treatment on ischemia-reperfusion injury after heart transplantation.
- Conditions
- Heart Failure, Respiratory Failure, Liver Failure, Kidney Failure
- Trial name
- SIMVA (NCT01160978)
- Testing
- Simvastatin 80mg, Control Rx
- Where
- Finland
- Volunteers
- 84 people, healthy volunteers welcome
- Sponsor
- Helsinki University Central Hospital
Liver Transplant; Complications, Immunosuppression
Blood-Bile Ratio Tacrolimus After Liver Transplantation
Tacrolimus is the most widely used immunosuppressive drug in the prevention of rejection after solid organ transplantation. Pharmacokinetic studies in healthy volunteers and in transplanted patients have shown that this molecule…
- Conditions
- Liver Transplant; Complications, Immunosuppression, Transplant Failure, Transplant; Complication, Rejection
- Trial name
- BBRT (NCT03882164)
- Testing
- Blood-Bile Ratio of Tacrolimus
- Where
- Italy
- Volunteers
- 55 people
- Sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Liver Transplant; Complications, Transplant; Failure, Liver
Liver Transplantation After ex Vivo Liver Perfusion
Today, it is difficult to predict liver function after transplantation and therefore livers where poor function is assumed (marginal livers) become discarded.
- Conditions
- Liver Transplant; Complications, Transplant; Failure, Liver, Transplant Dysfunction, Transplant; Complication, Rejection
- Trial name
- EVOLVE (NCT05951231)
- Testing
- Liver transplantation
- Volunteers
- 22 people
- Sponsor
- Oslo University Hospital
Liver Diseases, Liver Cancer
CRISPR-Edited HLA Donor Liver Transplant to Reduce Rejection
This early-phase clinical trial will assess the use of ex vivo CRISPR-Cas9 genome editing on donor liver grafts to reduce immunogenicity before transplantation.
- Conditions
- Liver Diseases, Liver Cancer, Liver Cirrhosis, Liver Failure
- Trial name
- NCT07053488
- Testing
- Ex Vivo CRISPR-Cas9 Gene Editing of Donor Liver
- Where
- China
- Volunteers
- 90 people
- Sponsor
- AMERICAN ORGAN TRANSPLANT AND CANCER RESEARCH INSTITUTE LLC
Liver Transplant Rejection, Immunosuppressant Adverse Reaction
Long-term Benefit of MPA in Liver Transplantation
MPA drugs are antiproliferative immunosuppressants and are widely used in solid organ transplantation. MPA drugs do not affect the recipient's kidney function and do not cause metabolic abnormalities and other problems.
- Trial name
- NCT05707520
- Testing
- enteric-coated mycophenolate (MPAs), None MPA
- Where
- China
- Volunteers
- 500 people
- Sponsor
- Third Affiliated Hospital, Sun Yat-Sen University