A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation
Status:
Completed
Trial end date:
2020-01-03
Target enrollment:
Participant gender:
Summary
This is a 24-month, Phase II, multi-center, two-arm, randomized controlled study of adult
patients receiving a single organ liver transplant from a deceased donor; the purpose being
to determine the efficacy of Thymoglobulin® induction and delayed initiation of CNI in the
long-term preservation of renal function after liver transplantation. This study is based on
the outcomes of an earlier phase 1 pilot study which was performed at the Cleveland Clinic.
This study will be conducted at 3 centers, with 110 subjects randomized 1:1 into two groups:
Group 1 will receive Thymoglobulin® induction, (4.5 mg/Kg, in 3 doses of 1.5 mg/Kg/dose) with
delayed initiation of CNI to begin on Day 10 post LT. Group 2 will receive early CNI
initiation (to be started no later than Day 2 post LT), and no Thymoglobulin® induction (or
any other antibody).
All subjects will also receive a maintenance immunosuppressive regimen consisting of
corticosteroids and mycophenolate mofetil (MMF) according to standard of practice in
orthotopic liver transplantation (OLT).
Subjects will be consented pre-transplant. Participation may last up to 12 months post OLT.
There are 15 study-related visits which will be completed during standard of care (SOC)
visits.