Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

NeuroTherapia, Inc.

Status: Completed

Conditions: Liver Transplantation

Treatments: Biological: Thymoglobulin 4.5mg total; Biological: Thymoglobulin 3mg total; Drug: tacrolimus 3-8; Drug: Mycophenolate mofetil; Drug: tacrolimus 8-12

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00970073

CCIRB 09-432

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

30 participants in 3 patient groups

Delayed CNI Group 1

Experimental group

Description:

Thymoglobulin 3mg total, administered on Days 0 and 2 (after transplant), plus MMF and corticosteroids. CNI administration delayed until 10 days post transplant. tacrolimus 3-8 (trough concentration)

Treatment:

Drug: Mycophenolate mofetil

Drug: tacrolimus 3-8

Biological: Thymoglobulin 3mg total

Delayed CNI Group 2

Experimental group

Description:

Thymoglobulin 4.5mg total, plus MMF and corticosteroids. CNI therapy delayed until 10 days post transplant.tacrolimus 3-8 (trough concentration)

Treatment:

Drug: Mycophenolate mofetil

Drug: tacrolimus 3-8

Biological: Thymoglobulin 4.5mg total

Early CNI / Control Arm

Active Comparator group

Description:

Standard post liver transplant therapy to include: tacrolimus 8-12 (trough concentration) initiated within 48 hours post-transplant, plus mycophenolate mofetil (MMF) and corticosteroids to be administered within 24 hours after transplant (Day 0).

Treatment:

Drug: tacrolimus 8-12

Drug: Mycophenolate mofetil