Phase 2
N=110
A Randomized Controlled Clinical Trial of Thymoglobulin® After Liver Transplantation
Liver Failure
Bottom Line
View on ClinicalTrials.gov: NCT02544113 ↗Enrolled (actual)
110
Serious AEs
23.6%
Results posted
May 2021
Primary outcome: Primary: The Incidence of Acute Kidney Injury (AKI) as Assessed by Change in Serum Creatinine From Baseline to 30 Days Post-transplant — .01; .06 mg/dL
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Thymoglobulin (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- The Cleveland Clinic
- Primary completion
- Jun 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Incidence of Acute Kidney Injury (AKI) as Assessed by Change in Serum Creatinine From Baseline to 30 Days Post-transplant |
.01; .06 | — |
| SECONDARY Number of Participants Experiencing Acute Cellular Rejection |
9; 7 | — |
| SECONDARY Graft Survival |
55; 55 | — |
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.
Eligibility 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.
Data sourced from ClinicalTrials.gov (NCT02544113). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.