Status:
TERMINATED
Everolimus Monotherapy as Immunosuppression After Liver Transplant
Lead Sponsor:
Indiana University
Conditions:
Kidney Failure
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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 si...
Detailed Description
Following enrollment, subjects will be randomized at one month post transplant to Tacrolimus (control) or to Everolimus (study) as maintenance immunosuppression. After liver transplant, all patients ...
Eligibility Criteria
Inclusion
- Liver transplant recipients \>= 18 years old
- Normal baseline renal dysfunction (GFR \> 60 mL/min)
- Rabbit anti-thymocyte globulin (rATG) induction (cumulative dose 1.5 - 5 mg/kg)
- Indication for transplant: ethanol, hepatitis C, or nonalcoholic steatohepatitis or any combination of these
Exclusion
- Increased risk of rejection: autoimmune hepatitis, primary biliary cirrhosis, primary sclerosing cholangitis, positive crossmatch, retransplantation
- Incompletely healed incision or other wound healing issues at time of randomization
- Multiple or previous organ transplantation
- Severe, uncontrolled hypercholesterolemia (\> 9mmol/L) or hypertriglyceridemia (\>8.5 mmol/L) in the 6 months prior to transplantation
- Insurance company unwilling to pay for the cost of the everolimus or patient does not qualify for the Novartis Patient Assistance Program.
- Pregnant women
- Unable to provide informed consent
Key Trial Info
Start Date :
May 9 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 2 2020
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT04063865
Start Date
May 9 2019
End Date
July 2 2020
Last Update
May 23 2023
Active Locations (1)
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1
IU Health University Hospital
Indianapolis, Indiana, United States, 46202