Mycophenolic Acid (MPA) Monotherapy in Liver Transplantation

Status Terminated

Clinical Trial Summary

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 increased acute rejection episodes or deterioration of liver allograft function.

Clinical Trial Description

The hypothesis to be tested is that donor-microchimerism in specific cell populations promotes the development of donor-specific regulation which in turn allows for long-term maintenance therapy with a single drug (Myfortic) in selected patients leading to superior long-term outcomes. Subjects will be enrolled post-transplantation and will be liver transplant recipients who meet the eligibility and exclusion criteria. We will use post-transplant monitoring for donor-specific immunologic regulation (DSR+/ DSA negative) to direct the withdrawal of patients to Myfortic monotherapy. Donor microchimerism, DSR, DSA development will be performed on samples obtained every six months from patients on study. The ultimate objective of the study is to use immunologic monitoring to develop a rational approach to achieving individualized immunosuppression for liver transplant patients. ;

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Liver Transplant

Clinical Trial Details

NCT number	NCT01230502
Study type	Interventional
Source	University of Wisconsin, Madison
Contact
Status	Terminated
Phase	N/A
Start date	November 2011
Completion date	June 2012

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02798861` - Controlled Attenuation Parameter (CAP) in Liver Allografts
Completed	`NCT03527238` - Optimizing Immunosuppression Drug Dosing Via Phenotypic Precision Medicine	Phase 2
Completed	`NCT01696331` - Text Messaging for Adherence in Adolescent Liver Transplant Recipients	N/A
Recruiting	`NCT05051605` - Immune Response to COVID-19 Vaccine in Recipients of Living Donor Liver Transplantation
Recruiting	`NCT05940857` - Sponsor-Initiated OCS Liver Perfusion (OLP-II) Registry
Completed	`NCT01598987` - Efficacy, Safety and Tolerability of Everolimus in Combination With Reduced Exposure Cyclosporine or Tacrolimus in Paediatric Liver Transplant Recipients.	Phase 3
Active, not recruiting	`NCT05074160` - OCS Liver Perfusion (OLP) Post-Approval Registry
Completed	`NCT05087550` - Multicenter Study on Organ Acquisition Costs in the Post Re-Allocation Era: Liver Transplantation
Recruiting	`NCT04836923` - LIFT Intervention in Liver Transplant Candidates	N/A
Not yet recruiting	`NCT03666689` - Outflow Reconstruction in Right Lobe Living Donor Liver Transplantation
Not yet recruiting	`NCT06088758` - Normothermic Machine Perfusion of Steatotic Livers for Expansion of Donor Organ Pool	N/A
Completed	`NCT00171509` - Efficacy and Safety of Cyclosporine Microemulsion Given Once a Day in Adult Stable Liver Transplant Recipients	Phase 4
Not yet recruiting	`NCT06254248` - Safety of Atezolizumab-Bevacizumab in Liver Transplanted Patients With Advanced Hepatocellular Carcinoma	Phase 2
Recruiting	`NCT06075745` - Cytomegalovirus (CMV) Vaccine in Orthotopic Liver Transplant Candidates	Phase 2
Not yet recruiting	`NCT06280950` - Expanding Liver Transplant Immunosuppression Minimization Via Everolimus	Phase 2
Completed	`NCT02057484` - A 5 Year Follow-up of Patients Who Were Previously Enrolled Into an Advagraf Trial Following a Liver or Kidney Transplant
Active, not recruiting	`NCT03577431` - Liver Transplantation With Tregs at MGH	Phase 1/Phase 2
Recruiting	`NCT06342557` - Transitional ePRO Diary Liver
Not yet recruiting	`NCT04265157` - Hepato-duodenal Ligament Occlusion and Classic Technique in Liver Transplant
Recruiting	`NCT02863250` - Australian and New Zealand Massive Transfusion Registry