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Low Dose Thymoglobulin to Protect Kidney Function After Liver Transplant

Information source: The Cleveland Clinic
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Liver Transplantation

Intervention: Thymoglobulin (Biological); Thymoglobulin (Biological); Mycophenolate mofetil (Drug); tacrolimus (Drug); tacrolimus (Drug)

Phase: N/A

Status: Active, not recruiting

Sponsored by: The Cleveland Clinic

Official(s) and/or principal investigator(s):
Bijan Eghtesad, MD, Principal Investigator, Affiliation: The Cleveland Clinic


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Reduced incidence of perioperative acute kidney injury in patients undergoing liver transplant as evidenced by kidney function measurement

Secondary outcome:

Patient survival

Graft survival

Allograft rejection rates at 30 days, 6 and 12 months as proven by biopsy

Renal function measured by eGFR


Minimum age: 18 Years. Maximum age: 70 Years. Gender(s): Both.


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


- 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 and Contacts

Cleveland Clinic (Main Campus), Cleveland, Ohio 44195, United States
Additional Information

Starting date: August 2009
Last updated: July 29, 2013

Page last updated: August 23, 2015

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