Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

• Status: Completed
• Trial end date: 2015-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Cleveland Clinic
• Collaborator: Genzyme, a Sanofi Company
• Treatments: Antilymphocyte Serum; Calcineurin Inhibitors; Mycophenolate mofetil; Mycophenolic Acid; Tacrolimus; Thymoglobulin

Criteria

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