A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation

• Status: Completed
• Trial end date: 2020-01-03
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Treatments: Antilymphocyte Serum; Calcineurin Inhibitors; Thymoglobulin

Criteria

Inclusion Criteria:

• Patients undergoing deceased donor solitary liver transplantation

• Age 18-75 years at the time of transplantation

• Willingness and ability to comply with the study procedures

• Signed informed consent form

• For patients with Hepatocellular carcinoma as indication for OLT, (must be within the Milan Criteria)

• Hepatitis C, positive or negative, patients

Exclusion Criteria:

• Prior kidney transplantation

• Congenital or iatrogenic absence of one kidney

• Subjects on renal replacement therapy at the time of OLT

• MELD score >34

• HIV positive patient

• Patient with current severe systemic infection

• History of bacterial peritonitis within 30 days prior to OLT

• Active infection or recent infection within 30 days prior to OLT

• Use of a calcineurin inhibitor continuously for more than 90 days within the past 6 months

• History of hypersensitivity to Thymoglobulin®, rabbits or tacrolimus

• Pregnant and/or nursing (lactating) females.

• Women of childbearing age who are unwilling to use effective contraception during the duration of the study, and for 30 days after study participation and/or last dose of Study Drug.