Everolimus Plus Mycophenolic Acid for Kidney Preservation in Liver Transplant Recipients With Impaired Kidney Function
Status:
Recruiting
Trial end date:
2029-12-31
Target enrollment:
Participant gender:
Summary
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. Replacement of Tacrolimus by Everolimus may have a
reduced incidence of renal dysfunction in liver transplant patients who already have chronic
kidney disease or peri-operative acute kidney injury. Liver transplant patients receive
potent induction immunosuppression in the form of rabbit anti thymocyte globulin.
Investigators believe that in conjunction with this induction regimen, patients can be
maintained on Everolimus monotherapy without the risk of rejection. Additionally, Everolimus
is known to induce tolerance in transplant recipients. Tolerant patients do not require
immunosuppression to accept transplant organs. Tacrolimus is a widely used in liver
transplant recipients for immunosuppression, however it is associated with nephrotoxicity.
Everolimus, on the other hand lacks nephrotoxicity. Whether replacement of tacrolimus by
Everolimus preserves kidney function in patients with pre-existing chronic kidney disease or
acute kidney injury is not well established. Also, the efficacy and safety of reduced-dose
Everolimus with or without Mycophenolate Mofetil in prevention of rejection is unknown.
Primary Aim Assess the effect of Everolimus with or without Mycophenolate Mofetil versus
Tacrolimus plus Mycophenolate Mofetil therapy on renal function measured by Glomerular
Filtration Rate (GFR). Secondary Aims
Compare the efficacy of Everolimus plus Mycophenolate Mofetil versus Tacrolimus plus
Mycophenolate Mofetil therapy as measured by the following:
- Biopsy-confirmed acute rejection
- Hyperlipidemia
- Proteinuria
- % regulatory T-cells in circulation
- NODAT [New Onset Diabetes mellitus After Transplant], hypertension and malignancy
- Tolerance measured by gene profiling at year 1, 2 and 3