Clinical trials: Immunosuppression After Liver Transplantation
Liver Transplant, Liver Transplantation
Evaluation of Donor Specific Immune Senescence and Exhaustion as Biomarkers of Tolerance Post Liver Transplantation
The primary aim of this study is to determine whether a peripheral blood or graft lymphocyte phenotype of immune senescence or exhaustion is different between operationally tolerant and non-tolerant liver allograft recipients.
- Trial name
- OPTIMAL (NCT02533180)
- Testing
- Immunosuppression withdrawal
- Where
- 7 sites in United States
- Volunteers
- 100 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Liver Transplantation
Biomarkers Predicting Successful Tacrolimus Withdrawal and Everolimus (Zortress) Monotherapy Early After Liver Transplantation
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.
- Trial name
- NCT02736227
- Testing
- Tacrolimus Withdrawal and Everolimus Monotherapy
- Where
- United States
- Volunteers
- 28 people
- Sponsor
- Northwestern University
Acute Cellular Graft Rejection, New Onset Diabetes After Transplant
Budesonide for Liver Transplant Immune Suppression
This is a pilot study that investigates the efficacy and safety of budesonide as an immune suppressing agent for liver transplant recipients in the early post-transplant period.
- Trial name
- NCT03304626
- Testing
- Budesonide 3Mg Capsule, Standard of Care Prednisone
- Where
- United States
- Volunteers
- 40 people
- Sponsor
- University of Cincinnati
Liver Transplantation
Phase 3b Study to Evaluate Advagraf in Combination With Mycophenolate Mofetil and Basiliximab in Liver Transplantation
Comparison of 3 dosing regimens of Advagraf to determine if there is a dosing regimen which may have the potential to cause fewer kidney problems.
- Trial name
- DIAMOND (NCT01011205)
- Testing
- Advagraf, Mycophenolate Mofetil, Basiliximab
- Where
- 72 sites in Argentina, Austria and 21 more
- Volunteers
- 893 people
- Sponsor
- Astellas Pharma Inc
Liver Transplantation, Immune Tolerance
Immune Tolerance Induction After Liver Transplantation
This clinical trial is being conducted to help liver transplant recipients safely discontinue toxic immunosuppressive drugs years after surgery.
- Conditions
- Liver Transplantation, Immune Tolerance, Immune Tolerance/Drug Effects, Graft Survival
- Trial name
- iTILT (NCT07269041)
- Testing
- Donor Hematopoietic Stem and Progenitor Cell Infusion
- Where
- United States
- Volunteers
- 12 people
- Sponsor
- University of California, Los Angeles
Transplant Complication
Using Transcriptional Assessment of Immune Response to Assess Immunosuppression After Liver Transplantation
To develop a prospective quantitative liver allograft monitoring protocol and retrospectively validate the use of Phenotypic personalized medicine (PPM) in immunosuppression dosing in liver transplant recipients.
- Trial name
- TGI (NCT06063213)
- Where
- United States
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- University of Florida
Liver Transplantation, Chronic Renal Insufficiency
Safety Study of Calcineurin-Inhibitor-Free Immunosuppression After Liver Transplantation
A prospective, non-randomized two stage monocentric phase II clinical trial to evaluate a de-novo calcineurin-inhibitor (CNI)-free immunosuppressive regimen based on induction therapy with anti-CD25 monoclonal anti-body…
- Trial name
- CILT (NCT00890253)
- Testing
- Basiliximab (Simulect), Myfortic, everolimus
- Where
- Germany
- Volunteers
- 29 people
- Sponsor
- Armin Goralczyk
Kidney Failure
Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Tacrolimus is the standard immunosuppressive drug used to prevent organ rejection post liver transplant. One side effect of Tacrolimus is nephrotoxicity. Everolimus does not have the nephrotoxicity side effects of Tacrolimus.
- Trial name
- NCT04258423
- Testing
- Tacrolimus, Everolimus
- Where
- United States
- Volunteers
- 4 people
- Sponsor
- Indiana University
Heart Transplantation, Liver Transplantation
Zoledronic Acid Versus Alendronate for Prevention of Bone Loss After Organ Transplantation
The purpose of this study is to compare the effectiveness and safety of zoledronic acid with alendronate in the prevention of bone loss after organ transplantation. Zoledronic acid is given as a single intravenous infusion.
- Conditions
- Heart Transplantation, Liver Transplantation, Bone Resorption
- Trial name
- CTX (NCT00297830)
- Testing
- Zoledronic acid, Alendronate
- Where
- United States
- Volunteers
- 111 people
- Sponsor
- Columbia University
Acute Cellular Graft Rejection, Liver Transplant Rejection
Budesonide for Immunosuppression After Liver Transplantation to Reduce Side Effects
Our hypothesis is that budesonide will provide effective hepatic ISP that will replace prednisone and allow lower systemic drug levels of FK, thus reducing the steroid- and calcineurin-associated complications often observed in…
- Trial name
- BILT (NCT03315052)
- Testing
- Budesonide, Tacrolimus（FK506）, Mycophenolate Mofetil
- Sponsor
- Montefiore Medical Center
Immunosuppression, Hepatocellular Carcinoma
Liver Transplantation Results in Hepatocellular Carcinoma Patients With Immunosuppression Without Steroids
The purpose of this study was to evaluate the safety and efficacy of a steroid-free immunosuppression protocol in Hepatocellular Carcinoma (HCC) patients.
- Conditions
- Immunosuppression, Hepatocellular Carcinoma, Liver Transplantation, Post-operative Complications
- Trial name
- NCT01137084
- Testing
- solu medrol, a steroid-free immunosuppression protocol
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Shanghai Jiao Tong University School of Medicine
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
Liver Transplantation, Immunosuppression
Evaluation of the Benefits of Administering Immunosuppressive Drugs as Single Daily Doses Over the First Year After Liver Transplantation (EASY)
World Health Organization considers non-adherence has a strong negative impact on the health of patients with chronic diseases. In transplantation, adherence to immunosuppressive drug regimens associates with late rejection and…
- Trial name
- EASY (NCT06354179)
- Testing
- XR-tacrolimus QD + MMF BID then MMF QD, XR-tacrolimus QD + MMF BID, LCP-tacrolimus QD + MMF QD then MMF QD
- Where
- 18 sites in France
- Volunteers
- 162 people
- Sponsor
- University Hospital, Limoges
Recipients of Liver Transplant
Envarsus XL Immunosuppression Following Liver Transplantation
The standard immunosuppressive regimen for liver transplantation includes twice daily tacrolimus (Prograf). In other transplantation models, there are potential benefits to extended release formulations as lower peak…
- Trial name
- NCT03828058
- Testing
- Envarsus XR, Prograf
- Where
- United States
- Volunteers
- 110 people
- Sponsor
- Methodist Healthcare - Memphis
Liver Transplantation
Comparison of Immunosuppression Protocols After LTx in Children
Open label, randomised, prospective, onecentre Investigator Driven Study: Comparison of two protocols of immunosuppression after liver Tx in children: A: Study group - FK506-MMF.
- Trial name
- NCT00195988
- Testing
- tacrolimus, steroids, mycophenolate mofetil
- Where
- Poland
- Volunteers
- 40 people
- Sponsor
- Children's Memorial Health Institute, Poland
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
Hepatitis C Virus Infection, Liver Transplantation
Effect of Immunosuppression Drug Weaning on Hepatitis C Virus (HCV)-Induced Liver Damage After Liver Transplantation
Viral infections can profoundly influence alloimmune responses and hamper allograft tolerance induction. Persistent hepatitis C virus (HCV) infection occurs in 50% of liver and 20% of kidney transplant recipients, but the impact…
- Trial name
- NCT00668369
- Testing
- Gradual immunosuppression drug withdrawal.
- Where
- Spain
- Volunteers
- 34 people
- Sponsor
- Hospital Clinic of Barcelona
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
SARS-CoV-2 Vaccination, Liver Transplantation
Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients
To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and…
- Trial name
- NCT05490342
- Testing
- Immunoassay, by ECLIA, for the quantitative in vitro determination of antibodies (including IgG) to the SARS - CoV - 2 spike protein (S) anti-RBD (receptor-binding domain) in serum and plasma samples.
- Where
- Italy
- Volunteers
- 61 people
- Sponsor
- University of Rome Tor Vergata
Single Transplant, 5 Years of Follow-up After Transplant, in Which an Attempt Was Made to Suspend IS
De Novo Metabolic Syndrome in Liver Transplant Patients After Immunosuppression Withdrawal
Evaluate de novo onset of metabolic syndrome, NAFLD and NASH in liver transplant recipients who have discontinued immunosuppressive therapy ("tolerant") and in those taking immunosuppressive therapy ("non-tolerant").
- Trial name
- NCT05808192
- Testing
- Immunosuppressive
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- University of Rome Tor Vergata