NCT00970073

Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

A Randomized Controlled Clinical Trial of Low Dose Thymoglobulin and Extended Delay of Calcineurin Inhibitor Therapy for Renal Protection After Liver Transplantation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: The Cleveland Clinic · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

• Liver Transplantation

Interventions

Type	Name	Description
BIOLOGICAL	Thymoglobulin 3mg total	1.5 mg/kg induction on Day 0 and 1.5 mg/kg induction on Day 2 (total of 3 mg/kg)
BIOLOGICAL	Thymoglobulin 4.5mg total	1.5 mg/kg induction on Days 0, 2 and 4 (total 4.5 mg/kg)
DRUG	Mycophenolate mofetil	1000 mg PO/IV BID for up to 6 months
DRUG	tacrolimus 3-8	Trough concentration between 3 ng/mL and 8 ng/mL starting on Day 10 and continuing beyond Day 180
DRUG	tacrolimus 8-12	Trough concentration between 8 ng/mL and 12 ng/mL on Days 0-10; between 6 ng/mL and 12 ng/mL on Days 10-30; between 6 ng/mL and 10 ng/mL Days 31-60; between 5 ng/mL and 8 ng/mL Days 61-179; and between 3 ng/mL and 8 ng/mL beyond Day 180.

Timeline

• Start date: 2009-08-01
• Primary completion: 2015-06-15
• Completion: 2015-12-01
• First posted: 2009-09-02
• Last updated: 2018-10-09
• Results posted: 2018-10-09

Locations

1 site across 1 country: United States