Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

The Cleveland Clinic30 enrolled

Overview

This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.

Strong anti-rejection drugs like tacrolimus or cyclosporine, are given to patients who have received transplants, to ensure that the patient's body does not reject the new organ. In some cases, while anti-rejection medications protect a newly transplanted liver, they can injure the patient's kidneys and cause them not to work as well as they should. The purpose of this pilot study is to determine the best way to protect kidney function and to ensure that the newly transplanted liver is not rejected. This study will evaluate the use of a drug called Thymoglobulin, combined with a delayed start of the anti-rejection drugs (10 days after liver transplant), compared to the current approach of starting anti-rejection drugs called calcineurin inhibitors or CNI's within 2 days after the liver transplant.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Liver Transplantation

Interventions

Thymoglobulin 3mg totalBIOLOGICAL

1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)

Thymoglobulin 4.5mg totalBIOLOGICAL

1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)

Mycophenolate mofetilDRUG

1000 mg PO/IV BID for up to 6 months

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients undergoing deceased donor solitary liver transplantation * Adults aged 18-70 at time of transplantation * Hepatocellular carcinoma as indication for OLT within the Milan Criteria * Hepatitis C positive or negative patients * Willingness to comply with study procedures * Able to sign informed consent Exclusion Criteria: * Prior kidney transplantation * Congenital or iatrogenic absence of one kidney * Subjects on renal replacement therapy at the time of OLT * MELD score \> 28 * 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 calcineurin inhibitor continuously for more than 90 days within the past 6 months * History of hypersensitivity to thymoglobulin, rabbits, tacrolimus or iohexol * Women of childbearing age who are unwilling to use effective contraceptive methods during the duration of the study

Locations (1)

Cleveland Clinic (Main Campus)

Cleveland, Ohio, United States

Outcomes

Primary Outcomes

Estimated Glomerular Filtration Rate (eGFR) at 12 Months Post-surgery

Postoperative acute kidney injury is measured as reduced (eGFR) within 12 months post-surgery.

Time frame: 12 Months

Secondary Outcomes

Patient Survival

Time frame: 12 months post-transplant

Graft Survival

90% graft survival, related to the deaths of 3 patients during the study period.

Time frame: 12 months post transplant

Allograft Rejection Rates at 30 Days

Acute Allograft Rejection

Time frame: 30 days

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.